3,957 Validation Analyst jobs in the United States

Job Description
Job Description:
We are looking for a Data Validation Analyst with strong expertise in Alteryx, SQL, Power BI, financial reporting, and enterprise data management (EDW). The role involves working across large and complex datasets, creating actionable insights, and enabling accurate reporting to support critical business decisions.
Key Responsibilities
- Develop and maintain Alteryx workflows to automate and streamline data processes.
- Write and optimize SQL queries to extract, validate, and analyze data.
- Design, build, and publish Power BI dashboards to provide meaningful insights.
- Support financial reporting by ensuring accuracy, consistency, and timeliness of data.
- Manage and maintain master data and ensure integrity across transactional/EDW systems.
- Partner with stakeholders to gather requirements and deliver scalable reporting solutions.
- Ensure data quality, governance, and adherence to reporting standards.
- Responsibilities are primarily centered around testing and data validation, with a focus on data governance.
- Supporting month end close, validation, and financial reporting
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: and Requirements
Qualifications
- Bachelor's degree in DATA Analytics, Computer Science, Finance, or related field (or equivalent experience).
- Proven hands-on experience with Alteryx, SQL, and Power BI.
- Strong understanding of financial reporting processes and business KPIs.
- Experience with enterprise data warehouses (EDW) and managing master/transactional data.
- Excellent analytical, problem-solving, and communication skills.
- Proficient in master data maintenance, transactional data validation, financial reporting, month-end close, SQL query development, data validation using Alteryx or similar tool , and building dashboards in Power BI(nice to have).
- less than 10 years of exp, prob like 7
- More junior role, not super technical Preferred Skills
- Experience with additional BI tools or ETL platforms.
- Exposure to data governance and process optimization.

**Job Description:**
+ The candidate in this role will be responsible for verifying the accuracy and quality of partner data, identifying opportunities to improve data QA processes, and triaging user feedback. The role requires close interaction with Engineering, Product, and Partnerships teams, as well as external partners.
**Responsibilities:**
+ Ensure the accuracy, completeness, and overall quality of partner data, especially polling locations, and early voting locations/hours, in order to ensure timely product launches.
+ Execute manual (online or offline) QA checks on partner data, including phone calls to validate data.
+ Identify and escalate data issues to multiple internal teams and external partners.
+ Compile, analyse, and report QA issues and trends to internal and external stakeholders, summarizing progress toward launch goals.
+ Triage incoming feedback or error reports to diagnose, reproduce, and resolve issues reported by client's users.
**Experience:**
+ 1+ years' experience in a professional setting.
+ Strong research, problem solving, and troubleshooting abilities.
+ Excellent organization skills and attention to detail.
+ Strong verbal and written communication skills.
+ Independent worker who can prioritize between competing, time-sensitive tasks, and context-switch effectively.
+ Respectful team player who can collaborate and support others.
+ Experience working in the areas of politics or government, especially with electoral and civic data, strongly preferred.
+ Availability to work extended business hours or weekends occasionally.
**About US Tech Solutions:**
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ( .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The **Validation Analyst II** is responsible for overall validation project ownership of moderate risk project(s) under mild supervision. Responsible for the generation and execution of validation protocols, assistance in audits, and determination of validation needs. This job has no supervisory responsibilities.
**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.
Performs validation activities to ensure compliance with government and customer requirements.
Prepares validation protocols, validation statements, reports, summaries, and master validation plans for new customer/product/system project launch and maintains existing validated processes/programs at multiple sites, as well as organizing and coordinating internal and customer approvals, as needed.
Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.
Prepares change control and validation history report for audits.
Attends conference calls and meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager.
Investigate validation deviations, documenting in formal reports, and ensuring resolution of corrective action to complete the project.
Primary contact for quality validation activities and managing expectations.
Reviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols.
Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11, and Annex 11 policies, procedures, rules, and requirements.
Required to complete and pass a "Documentation Boot Camp" course within 6 months.
This position may require overtime and/or weekend work.
Attendance at work is an essential function of this position.
Performs other duties as assigned.
"Moderate Risk Projects" are generally defined as projects/customer accounts that have the following.
a. Business needs of the customer/project may require additional time commitments.
b. Moderate level of uncertainty in managing customer expectations.
c.Validation approach with moderately complex requirements in addition to the Validation Plan.
d. Established criteria that are subject to some interpretation.
After basic training, this position will be required to specialize in 1 or more Validation areas of focus:
a. Process/Cleaning Validations
b. HVAC/Utility Validations
c. Computer Validations
**Qualifications:** The requirements listed below are representative of the knowledge, _skills_ , and/or _abilities_ required for the stated position. Reasonable _accommodation_ may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
**High School Diploma or GED** and/or 3-5 years related experience and/or training.
**College-Level Mathematical Skills.**
**Intermediate Computer Skills:** Ability to perform more complex computer tasks and know various computer programs.
**Minimum Professional Proficiency:** Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.
**Intermediate Reasoning:** Ability to apply common-sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.
**Preferred:**
**Process/Cleaning Validation Focus:** Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices. Must be able to properly gown and work in an active packaging operation.
**HVAC/Utility Validation Focus:** Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems.
**Computer Validation Focus:** _Associate's Degree in a related field and/or 1-3 years related experience and/or training._ Ability to perform complex computer tasks and have some experience with computer systems considered to have an impact on cGMP, cGXP, Annex 11, and PCI guidelines.
**For candidates in Illinois:** The hiring rate for this position is $ $2.15 - 24.92 hourly, plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k)
#LI-SW1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The **Validation Analyst III** is responsible for overall validation project ownership of large risk project(s) under mild supervision. Responsible for the generation and execution of validation protocols, assistance in audits, and determination of validation needs. This job has no supervisory responsibilities.
**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.
Performs validation activities to ensure compliance with government and customer requirements.
Prepares validation protocols, validation statements, reports, summaries, and master validation plans for new customer/product/system project launch and maintains existing validated processes/programs at multiple sites, as well as organizing and coordinating internal and customer approvals, as needed.
Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.
Prepares change control and validation history report for audits.
Attends conference calls and meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager.
Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete the project.
Primary contact for quality validation activities and managing expectations.
Reviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols.
Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11, and Annex 11 policies, procedures, rules, and requirements.
Required to complete and pass a "Documentation Boot Camp" course within 6 months.
This position may require overtime and/or weekend work.
Attendance at work is an essential function of this position.
Performs other duties as assigned.
"Large Risk Projects" are generally defined as projects/customer accounts that have the following.
a. Business needs of the customer/project may require additional time commitments.
b. Advanced level of uncertainty in managing customer expectations.
c. Validation approach with advanced complex requirements in addition to the Validation Plan.
d. Established criteria that are subject to advanced interpretation.
After basic training, this position will be required to specialize in the following Validation area of focus:
a. HVAC/Utility Validations
**Qualifications:** The requirements listed below are representative of the knowledge, _skills_ , and/or _abilities_ required for the stated position. Reasonable _accommodation_ may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
**Associate's Degree in a related field** and/or 1-3 years related experience and/or training.
**College-Level Mathematical Skills.**
**Intermediate Computer Skills:** Ability to perform more complex computer tasks and know various computer programs.
**Full Professional Proficiency:** Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
**High Reasoning:** Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
**Preferred:**
**HVAC/Utility Validation Focus:** Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems.
**For candidates in Illinois:** The hiring rate for this position is $27.27 to $30.68 hourly, plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and 401(k).
#LI-SW1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The **Validation Analyst III** is responsible for overall validation project ownership of large risk project(s) under mild supervision. Responsible for the generation and execution of validation protocols, assistance in audits, and determination of validation needs. This job has no supervisory responsibilities.
**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.
Performs validation activities to ensure compliance with government and customer requirements.
Prepares validation protocols, validation statements, reports, summaries, and master validation plans for new customer/product/system project launch and maintains existing validated processes/programs at multiple sites, as well as organizing and coordinating internal and customer approvals, as needed.
Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.
Prepares change control and validation history report for audits.
Attends conference calls and meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager.
Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete the project.
Primary contact for quality validation activities and managing expectations.
Reviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols.
Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11, and Annex 11 policies, procedures, rules, and requirements.
Required to complete and pass a "Documentation Boot Camp" course within 6 months.
This position may require overtime and/or weekend work.
Attendance at work is an essential function of this position.
Performs other duties as assigned.
"Large Risk Projects" are generally defined as projects/customer accounts that have the following.
a. Business needs of the customer/project may require additional time commitments.
b. Advanced level of uncertainty in managing customer expectations.
c. Validation approach with advanced complex requirements in addition to the Validation Plan.
d. Established criteria that are subject to advanced interpretation.
After basic training, this position will be required to specialize in the following Validation area of focus:
a. HVAC/Utility Validations
**Qualifications:** The requirements listed below are representative of the knowledge, _skills_ , and/or _abilities_ required for the stated position. Reasonable _accommodation_ may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
**Associate's Degree in a related field** and/or 1-3 years related experience and/or training.
**College-Level Mathematical Skills.**
**Intermediate Computer Skills:** Ability to perform more complex computer tasks and know various computer programs.
**Full Professional Proficiency:** Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
**High Reasoning:** Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
**Preferred:**
**HVAC/Utility Validation Focus:** Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems.
**For candidates in Illinois:** The hiring rate for this position is $27.27 to $30.68 hourly, plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and 401(k).
#LI-SW1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
This is a fully onsite role based at our customer's site in New Brunswick, NJ. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
The primary focus of the System Specialist role is to work as part of a team that provides business ownership of select software systems throughout their lifecycle. These systems will support both GxP and non-GxP operations across all ASO sites. This role will collaborate with laboratory staff, IT personnel, and QA members to facilitate the timely delivery of lifecycle activities. In addition, management of master systems data as well as end-user management of collaborative systems (i.e., SharePoint) may be required. The anticipated division is expected to be 70% system lifecycle activities and 30% management of master systems data.
**Key responsibilities:**
+ Manage and deliver on a list of assignments, with a particular focus on timeline, scope, and budget.
+ Maintain close communication with team members to keep apprised of system status, project status, impact on laboratory operations, and other relevant items.
+ Collaborate with various cross functional colleagues (i.e., scientists, instrument vendors, QA, and IT colleagues) to evaluate opportunities for new digital capabilities in support of continuous improvement activities, setup and qualify new systems or upgrade existing systems for the ASO testing laboratories.
+ Become an active participant in acquisition and divestiture activities, including planning for the consolidation of duplicated systems and activities.
+ For assigned systems, aggregate/manage information from various sources to maintain an overall system status. This information may include roadmap/obsolesce data, risk/issue lists, feature requests.
+ Apply FDA CFR 251 Part 11/EU Annex 11 GAMP 5, and other applicable global health authority regulations to the lifecycle of computer systems to ensure they are in a validated state, supporting regulated business processes and computer software assurance.
+ Follow SOPs and industry best practices.
+ Author and/or review validation deliverables including requirement and design specifications, summary reports, pre/post executed test scripts and procedures for supported systems. Execute test scripts to prove compliance with system requirements.
+ For assigned systems, support operational and compliance initiatives such as periodic reviews of systems, SOP updates, training materials, user requested enhancements, and system audit trail assessments.
+ Assist in the preparation of assigned systems for audit readiness.
+ Facilitate audits and participate in the identification or resolution of CAPAs and other QEs.
+ Develop standard operating procedures, work instructions, and other quality documents as needed to ensure the integrity of both the laboratory data collected and the systems used to collect the data.
**Education and Experience:**
+ Bachelor's degree in a Scientific or IT field or similar
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years')
+ OR Masters degree
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills and Abilities:**
+ Hands-on laboratory-system experience (LIMS, Chromatography Data Systems, or other relevant platforms), in an environment governed by GMP regulations or equivalent experience.
+ Experience in acquisition/divestiture activities is a plus.
+ Hands on experience managing the business configuration of collaborative tools, like SharePoint, particularly translating business needs into a functional design while maintaining an appropriate security posture is also a benefit.
+ Excellent oral and written communication skills in English. In addition, above average competency with the Microsoft Office suite.
+ Ability to perform in a highly matrixed organization structure.
+ Possess expertise on Good Documentation and Good Testing Practices and solid grasp of cGMPs and Computer System Validations.
+ Experience with electronic document management systems (e.g., Veeva platform, SharePoint etc.) and application development and lifecycle management systems (e.g., ALM, ValGenesis, etc.)
+ Experience with the complete system lifecycle for both regulated and non-regulated systems.
+ Experience developing and delivering training for scientific software systems.
**Working Environment:**
Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with
proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
**Benefits**
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Validation Analyst II, Albuquerque, NM
Build your future at Curia, where our work has the power to save lives
Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.
We proudly offer
+ Generous benefit options (eligible first day of employment)
+ Paid training, vacation and holidays (vacation accrual begins on first day of employment)
+ Career advancement opportunities
+ Education reimbursement
+ 401K program with matching contributions
+ Learning platform
+ And more!
Summary:
The Validations Department is responsible for formulating, reviewing, and approving all validation protocols related to manufacturing or support operations. The Validation Analyst II is responsible for executing and supporting validation activities for equipment, processes, utilities, systems, and components in alignment with cGMP regulations, internal procedures, and applicable regulatory expectations.
This intermediate-level role involves authoring, reviewing, and executing validation protocols; analyzing test results; and compiling final reports to support qualification and ongoing validation efforts. The Validation Analyst II collaborates with cross-functional teams to ensure validation work is efficiently integrated into production and quality timelines. This role may also support investigations related to validation deviations, participate in risk assessments, and contribute to the development and continuous improvement of validation practices.
Essential Duties and Responsibilities:
+ Execute validation and qualification protocols for equipment, utilities, systems, and processes in accordance with cGMP, internal procedures, and regulatory requirements.
+ Author and execute test scripts, accurately document validation data, and compile final reports to support qualification and release of validated items.
+ Conduct small to medium validation projects under general supervision:
+ Small projects: 1-2 test scripts, a single system or piece of equipment, one end customer, duration less than 1 month.
+ Medium projects: 2-5 test scripts, multiple systems or pieces of equipment, multiple end customers, duration between 1-3 months.
+ Review and verify validation documentation to ensure information is complete, accurate, and compliant with regulatory expectations.
+ Coordinate with cross-functional teams (e.g., Quality, Manufacturing, Engineering) to ensure validation efforts align with production and quality timelines.
+ Participate in change controls, investigations, and deviations as they relate to validation activities.
+ Understand and implement site safety procedures and current Good Manufacturing Practices (cGMP).
+ Support departmental initiatives and continuous improvement efforts, including Operational Excellence projects.
+ Stay current with industry regulations and best practices by reviewing pharmaceutical and regulatory publications.
+ Notify management and team members of changes that may impact internal SOPs or validation requirements.
+ Train and mentor junior validation staff, including Validation Technicians and Senior Technicians, on core validation tasks and documentation practices.
+ Compile data into well-defined reporting formats and conduct basic comparative data analyses to support validation conclusions.
+ Read/interpret SOPs to ensure compliance
+ Maintain up to date trainings
+ Other duties as assigned
Education and Experience:
+ Bachelor's degree in Computer Engineering , Physical Sciences, or relevant field of study
+ Minimum of three (3) years validation or related work experience
+ Knowledge of regulatory requirements, including FDA regulations, ISO 9000-3, PIC/S guidelines for cGMP, and GAMP 4 and 5 based on the GAMP V-Model Framework, as well as EU GMP Annex 11 for computer systems compliance
Supervisory Responsibilities:
This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.
Language Skills:
The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.
Mathematical Skills:
Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Computer Skills:
The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
Other Skills and Abilities:
+ Provides guidance and mentorship to team members
+ Fosters a collaborative and positive work environment
+ Champions change
+ Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
+ Demonstrates strong attention to detail
+ Demonstrates working knowledge of internal standards for written communication as they apply to controlled document changes/revisions.
+ Verbally expresses ideas, facts, and proposals that are clear, logical, concise, and in accepted grammatical style.
+ Independently prepares written communications in accepted grammatical style, which need little or no editorial corrections, and submit for review by supervision or a designee before being issued.
Other Qualifications:
+ Must pass a background check
+ Must pass a drug screen
+ May be required to pass Occupational Health Screening
+ May be required to obtain and maintain gowning certification
+ May be required to obtain and maintain media qualification
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The essential physical demands will vary for each Curia position.
All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.
Work Environment:
The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.
The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.
The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.
The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.
Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.
All environments may be subject to working with or being exposed to cleaning agents.
#LI-MM2

SMBC Group is a top-tier global financial group. Headquartered in Tokyo and with a 400-year history, SMBC Group offers a diverse range of financial services, including banking, leasing, securities, credit cards, and consumer finance. The Group has more than 130 offices and 80,000 employees worldwide in nearly 40 countries. Sumitomo Mitsui Financial Group, Inc. (SMFG) is the holding company of SMBC Group, which is one of the three largest banking groups in Japan. SMFG's shares trade on the Tokyo, Nagoya, and New York (NYSE: SMFG) stock exchanges.
In the Americas, SMBC Group has a presence in the US, Canada, Mexico, Brazil, Chile, Colombia, and Peru. Backed by the capital strength of SMBC Group and the value of its relationships in Asia, the Group offers a range of commercial and investment banking services to its corporate, institutional, and municipal clients. It connects a diverse client base to local markets and the organization's extensive global network. The Group's operating companies in the Americas include Sumitomo Mitsui Banking Corp. (SMBC), SMBC Nikko Securities America, Inc., SMBC Capital Markets, Inc., SMBC MANUBANK, JRI America, Inc., SMBC Leasing and Finance, Inc., Banco Sumitomo Mitsui Brasileiro S.A., and Sumitomo Mitsui Finance and Leasing Co., Ltd.
The anticipated salary range for this role is between $82,000.00 and $96,000.00. The specific salary offered to an applicant will be based on their individual qualifications, experiences, and an analysis of the current compensation paid in their geography and the market for similar roles at the time of hire. The role may also be eligible for an annual discretionary incentive award. In addition to cash compensation, SMBC offers a competitive portfolio of benefits to its employees.
**Role Description**
SMBC is seeking a qualified individual as a Model Validation Analyst that will report to the Compliance Model Validation Manager, in the Risk Management Department, Americas Division. The Compliance Model Validation Analyst will perform the validation of all compliance models for SMBC
**Role Objectives**
Document model development to standards consistent with regulatory expectation. Validate suitability of models for business purpose and according to internally developed standards. Assist in drafting policies and procedures for model development and maintenance. Audit policies and procedures. Create a number of backtesting methodologies to ensure models are producing expected results. Help validate model tuning for changes in transaction levels / types, market conditions and risk appetite.
**Role Responsibilities**
+ Conduct end-to-end validations and reviews of BSA/AML/Fraud models, assessing model risk from the aspects of conceptual soundness, data quality, model/scenarios design, model usage, model implementation, model performance, model control and ongoing performance monitoring
+ Identify model deficiencies through validations, communicate the issue with model owners and senior management, and provide feasible and adequate recommendations
+ Develop and maintain documentation templates, testing packages and automation tools/scripts to standardize validation processes
+ Support audits and examinations for compliance and fraud risk models
+ Maintain up-to-date knowledge in AML/fraud regulations and industry best practice
**Qualifications and Skills**
+ Minimum master's or equivalent degree in Statistics, Mathematics, Engineering, Computer Science or related fields
+ Preferred experience in compliance analytics, BSA/AML model validations, or related domains in financial institutions or consultancies
+ Working knowledge in data science, with capability to cleanse, parse, restructure, and validated large datasets
+ Experience of developing/validating machine learning models is preferred
+ Familiarity with Oracle Database, Actimize SAM, and Fircosoft preferred
+ Proficient in programming in SQL, Python/R, Hadoop and familiarity with Azure Cloud environment. Full stack knowledge is a plus but not compulsory.
+ Good understanding of the finance industry and business lines
+ Strong reasoning ability, analytical skills, and communication
**Additional Requirements**
SMBC's employees participate in a Hybrid workforce model that provides employees with an opportunity to work from home, as well as, from an SMBC office. SMBC requires that employees live within a reasonable commuting distance of their office location. Prospective candidates will learn more about their specific hybrid work schedule during their interview process. Hybrid work may not be permitted for certain roles, including, for example, certain FINRA-registered roles for which in-office attendance for the entire workweek is required.
SMBC provides reasonable accommodations during candidacy for applicants with disabilities consistent with applicable federal, state, and local law. If you need a reasonable accommodation during the application process, please let us know at

**About the role**
As a **Senior QA Validation Analyst** , you will make an impact by leading the testing and validation strategy for Electronic Lab Notebook (ELN) systems and their integration platforms. You will be a valued member of the Life Sciences team and work collaboratively with cross-functional stakeholders including QA, IT, and business partners across geographies.
**In this role, you will:**
+ Lead the validation and testing strategy for ELN systems, ensuring robust and efficient processes.
+ Oversee testing activities to guarantee seamless integration across platforms.
+ Utilize ALM tools (e.g., HP ALM, JIRA) to manage and streamline testing workflows.
+ Collaborate with R&D teams to align testing efforts with project goals.
+ Develop and execute comprehensive test plans and cases covering all functional requirements.
+ Monitor testing progress, report outcomes, and address issues proactively.
+ Ensure adherence to company policies and industry best practices.
+ Mentor junior testers and foster a culture of continuous improvement.
+ Analyze test results to provide actionable insights for product enhancements.
+ Communicate testing outcomes and recommendations to stakeholders.
+ Drive innovation in testing methodologies to improve efficiency and effectiveness.
**Work model:**
We believe hybrid work is the way forward as we strive to provide flexibility wherever possible. Based on this role's business requirements, this is a **hybrid position requiring 2-3 days a week** in a client or Cognizant office in **Boston, MA** . Regardless of your working arrangement, we are here to support a healthy work-life balance through our various wellbeing programs.
**What you need to have to be considered:**
+ Proven expertise in managing the full testing lifecycle: URS, Risk Assessment, System Testing, Integration Testing, UAT, Traceability Matrix, and Test Summary Reports.
+ Strong documentation and audit readiness skills, including authoring and reviewing test plans and traceability matrices.
+ Experience in the pharmaceutical or life sciences domain.
+ Hands-on experience with ELN systems and integration platforms; familiarity with Benchling is a plus.
+ Ability to lead cross-functional teams and coordinate across QA, IT, and business stakeholders.
+ Skilled in managing testing deliverables across geographies and time zones.
+ Familiarity with Agile, Waterfall, and V-Model SDLC approaches.
+ Proficiency in tools such as HP ALM, JIRA, ServiceNow, and SharePoint.
+ Strong communication skills and stakeholder engagement capabilities.
+ Proactive approach to problem-solving and process improvement.
+ Commitment to continuous learning and professional development.
**These will help you stand out:**
+ Experience with data validation, integration testing, and analytics platforms.
+ Thought leadership in testing innovation and methodology improvements.
+ Ability to translate test outcomes into strategic recommendations for product enhancement.
+ Demonstrated success in mentoring and developing testing talent.
+ Familiarity with regulatory compliance and audit processes in life sciences.
+ Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship
We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.
**·** **_Salary and Other Compensation:_**
· The annual salary for this position is between ($53,477/- to $92,500/-) depending on experience and other qualifications of the successful candidate.
· This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.
**·** **_Benefits:_**
· Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
· Medical/Dental/Vision/Life Insurance
· Paid holidays plus Paid Time Off
· 401(k) plan and contributions
· Long-term/Short-term Disability
· Paid Parental Leave
Employee Stock Purchase Plan
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.