7,051 Senior Validation jobs in the United States

Responsibilities:

• Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems.
• Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.).
• Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems.
• Author validation life cycle documents for client's review and approval.
• Route drafted documents for review.
• Route reviewed documents for workflow approval.
• Request approval workflows to Doc Control.
• Execute approved protocols in GxP facility.
• Understand SDLC process and SDLC methodology such as agile etc.
• Work with different stakeholders (IT, Network, Vendor) team in delivering validation project deliverables.
• Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area.
• Author change control documents for client review and approval.

Requirements:

• Prior experience with benchtop instrument experience is a must.
• Bachelor's/ master's degree or equivalent in a scientific or health care field.
• 7+ years' experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred.
• Prior experience with benchtop instrument experience is a must.

We are looking for Quality Assurance Validation contractors to join our growing QA Validation group in Boston MA.  Positions range from 6 to 12 months. The roles are expected to be onsite in Boston, MA. 

Responsibilities:

• Provide QA oversight of CQV activities for the cGMP manufacturing facility and quality control laboratories.

• Provide QA oversight for periodic review and requalification program.
• Perform review of CMMS records related to asset management including asset release, database requests, and work orders.
• Author and perform review of SOPs in Veeva.

• Review and approve validation protocols and reports (IQ, OQ, PQ, CSV, process validation, cleaning validation).
• Ensure compliance of validation activities with applicable GMP regulations, industry guidance, and internal SOPs.
• Collaborate with cross-functional teams (Validation, QA, Engineering, Manufacturing, QC) to support timely execution of validation projects.
• Participate in change control assessments, risk assessments, and deviation investigations related to validation.
• Provide QA input during validation planning and execution phases.
• Support audits and regulatory inspections by providing validation documentation and addressing QA-related inquiries.
• Ensure data integrity and documentation accuracy in all validation records.
• Maintain cu

Requirements

Requirements:

• Bachelor’s degree in a technical discipline with 5+ years validation and/or quality assurance experience. In lieu of degree, 7+ years of equivalent work experience is required. 
• Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, risk-based validation.  
• Prior experience working in cell and gene therapy manufacturing preferred. 
• Prior experience working with contract manufacturing preferred. 
• Experience with Kneat strongly preferred. 
• Applies collaborative approach to problem solving and is experienced with risk-based decision making. 
• Team player who works well in large multi-disciplinary project groups by listening effectively and inviting open discussion.

Benefits

• Contract
• 6 to 12 months

Location: Rensselaer, New York – ON SITE

**This role will require the successful candidate to be on-site in Rensselaer, NY**

**This role is not eligible for relocation assistance**

Description: Zifo is working with a large pharma client to build a team of laboratory IT (lab computing, Lab IT systems, QA, Validation) professionals. This role will require a 100% on-site presence in Rensselaer, NY.

Requirements

Responsibilities:

• Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems
• Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.)

• Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems
• Author validation life cycle documents for client’s review and approval

• Route drafted documents for review

• Route reviewed documents for workflow approval
• Request approval workflows to Doc Control

• Execute approved protocols in GxP facility
• Understand SDLC process and SDLC methodology such as agile etc.
• Work with global team in delivering validation project deliverables
• Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area
• Author change control documents for client review and approval

Qualifications:

• Prior experience with benchtop instrument experience is a must

• Bachelor’s/ Master’s degree or equivalent in a scientific or health care field.
• 7+ years' experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred.

A successful Zifo-ite is:

• Independent, Self-Motivated & Results driven
• Willing & able to quickly acquire new Technical Skills & Business Principles
• A critical thinker who possesses logical reasoning
• Curious and always looking for creative solutions to complex problems

Benefits

CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 7 of the Top 10 Biopharma companies.

We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a “no doors” policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability.

If you share these sentiments and are prepared for the atypical, then Zifo is your calling!

Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Software Validation & Quality Assurance Principal Engineer

Hybrid

Onsite 3times a week (tuesday, Wedneday, Thursday), working from home 2x a week.

Santa Clara, CA

Work closely with peers in a team of skilled engineers designing and developing networking software for Switch Products.

All team members participate in SDK qualifications and will work on the following areas:
• Design test strategy and test plan of your SDK features
• Validate forwarding and datapath features on switch ASIC
• Develop automated tests in one of programming languages (preferably python)
• Work with architect and development team to deliver SDK release with solid quality

What We're Looking For

Bachelor's degree in Computer Science, Electrical Engineering or related fields and 10-15 years of related professional experience. OR Master's degree and/or PhD in Computer Science, Electrical Engineering or related fields with 5-10 years of experience.

Must have a strong passion for the latest technologies and strong problem solving and troubleshooting skills.

Proficient in one or multiple programming languages (preferably python)

Strong analytical skills and strong debugging skills

A team player with good communication skills

Work experience in one or multiple of the following areas:
• Layer 2/Layer 3 protocols, QoS, ACL
• MPLS, IPinIP, VxLAN, IPGRE Tunnels
• Datapth features like buffer management, queueing, shaping, metering, AQM/ECN etc.
• Familiar with CI/CD tools: GitLab, Jenkins etc

Current Employees: If you are currently employed at any of the Universities of Wisconsin, log in to Workday to apply through the internal application process.

Job Category:
Academic Staff

Employment Type:
Regular

Job Profile:
IT Business Analyst II

Job Duties:

The University of Wisconsin-Madison School of Medicine and Public Health (SMPH) is embarking on an exciting mission of establishing state of the art data and informatics infrastructure to support cutting edge biomedical research. We are seeking a Research Quality Assurance (QA) and Validation Specialist to lead software validation efforts for FDA regulated projects. This position will work with research teams to define user requirements and write test cases to validate research projects.

It is anticipated that this position will be remote and requires work be performed at an offsite, non-campus work location.

Key Job Responsibilities:

• Performs analyses and prepares reports to ensure that programs meet or exceed schedule commitments

• May work with external vendors or service providers

• Determines and recommends programs required for optimal problem solution within cost/performance objectives

• Trains, serves as a resource, and provides guidance to other IT business analysts on routine problems, work processes, and policies

• Formulates and defines systems scope and objectives through research and fact-finding combined with an understanding of applicable business systems and industry requirements

• Participates in requirements planning and feasibility determination

• Works on tasks including project or functional requirements, functional design, functional configuration, testing, and documentation

• Devises or modifies moderately complex information systems including analysis of business and user needs, documenting requirements, and revising existing system logic difficulties as necessary

• Leads and executes validation for software and projects to maintain FDA 21 CFR Part 11 compliant systems

Department:

School of Medicine and Public Health, Office of Informatics and Information Technology, Applications Support.

This position is within the School of Medicine and Public Health's Office of Informatics and Information Technology (IIT). IIT is a multidisciplinary team of data scientists, engineers, developers, and IT support staff. We offer a variety of Informatics and IT services to departments and research staff within the School of Medicine and Public Health and beyond to support the conduct of high-quality clinical and translational research.

• Informatics: We provide innovative solutions and training for a broad spectrum of clinical and translational research utilizing real-world data to facilitate rapid translation of research findings into clinical practice, with an emphasis on precision medicine, healthcare delivery, and population health.
• Technology Solutions: We provide technology solutions to the School of Medicine and Public Health including cybersecurity, educational technology, and IT support.

Compensation:

The starting salary for the position is $70,000 but is negotiable based on experience and qualifications.

Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. For more information, refer to the campus benefits webpage and the SMPH Academic Staff Benefits Flyer

Required Qualifications:

• Minimum two years of systems experience in software support, development or testing

• Strong organizational, analytical, verbal and written communication skills

Preferred Qualifications:

• Experience writing system documentation and standard operating procedures

• Experience with REDCap data collection system

• Experience performing research data collection and data management

• Experience gathering user requirements and writing test cases

• Experience working in GxP environment or validation work to meet 21 CFR Part 11 requirements

Education:

Bachelor's degree preferred

How to Apply:

To apply for this position, please click on the "I am a current employee" button or "I am not a current employee" button under Apply Now. You will be prompted to upload the following documents.

• Cover Letter
• Resume

Please note, there is only one attachment field. You must upload all of your documents in the attachment field.

Applicants are to submit a cover letter and resume detailing their training and experience relating to the required and preferred qualifications referenced above. The application reviewers will be relying on written application materials to determine which qualified applicants will advance in the recruitment process. We will notify selected applicants to participate further in the selection process directly. References will be requested of final candidates. All applicants will be notified after the search is complete and a candidate has been selected.

Contact Information:

Cody Roekle,

Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.

The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.

For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

The University of Wisconsin-Madison is an Equal Opportunity Employer.

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgrounds and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, click here.

To request a disability or pregnancy-related accommodation for any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR) in the division you are applying to. Please make your request as soon as possible to help the university respond most effectively to you.

Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment.

The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).

The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.

Current Employees: If you are currently employed at any of the Universities of Wisconsin, log in to Workday to apply through the internal application process.

Job Category: Academic Staff

Employment Type: Regular

Job Profile: IT Business Analyst II

Job Duties:
The University of Wisconsin-Madison School of Medicine and Public Health (SMPH) is embarking on an exciting mission of establishing state of the art data and informatics infrastructure to support cutting edge biomedical research. We are seeking a Research Quality Assurance (QA) and Validation Specialist to lead software validation efforts for FDA regulated projects. This position will work with research teams to define user requirements and write test cases to validate research projects.

It is anticipated that this position will be remote and requires work be performed at an offsite, non-campus work location.

Key Job Responsibilities:

• Performs analyses and prepares reports to ensure that programs meet or exceed schedule commitments

• May work with external vendors or service providers

• Determines and recommends programs required for optimal problem solution within cost/performance objectives

• Trains, serves as a resource, and provides guidance to other IT business analysts on routine problems, work processes, and policies

• Formulates and defines systems scope and objectives through research and fact-finding combined with an understanding of applicable business systems and industry requirements

• Participates in requirements planning and feasibility determination

• Works on tasks including project or functional requirements, functional design, functional configuration, testing, and documentation

• Devises or modifies moderately complex information systems including analysis of business and user needs, documenting requirements, and revising existing system logic difficulties as necessary

• Leads and executes validation for software and projects to maintain FDA 21 CFR Part 11 compliant systems

Department:
School of Medicine and Public Health, Office of Informatics and Information Technology, Applications Support.

This position is within the School of Medicine and Public Health's Office of Informatics and Information Technology (IIT). IIT is a multidisciplinary team of data scientists, engineers, developers, and IT support staff. We offer a variety of Informatics and IT services to departments and research staff within the School of Medicine and Public Health and beyond to support the conduct of high-quality clinical and translational research.

• Informatics: We provide innovative solutions and training for a broad spectrum of clinical and translational research utilizing real-world data to facilitate rapid translation of research findings into clinical practice, with an emphasis on precision medicine, healthcare delivery, and population health.
• Technology Solutions: We provide technology solutions to the School of Medicine and Public Health including cybersecurity, educational technology, and IT support.

Compensation:
The starting salary for the position is $70,000 but is negotiable based on experience and qualifications.

Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. For more information, refer to the campus benefits webpage and the SMPH Academic Staff Benefits Flyer

Required Qualifications:

• Minimum two years of systems experience in software support, development or testing

• Strong organizational, analytical, verbal and written communication skills

Preferred Qualifications:

• Experience writing system documentation and standard operating procedures

• Experience with REDCap data collection system

• Experience performing research data collection and data management

• Experience gathering user requirements and writing test cases

• Experience working in GxP environment or validation work to meet 21 CFR Part 11 requirements

Education:
Bachelor's degree preferred

How to Apply:
To apply for this position, please click on the "I am a current employee" button or "I am not a current employee" button under Apply Now. You will be prompted to upload the following documents.

• Cover Letter
• Resume

Please note, there is only one attachment field. You must upload all of your documents in the attachment field.

Applicants are to submit a cover letter and resume detailing their training and experience relating to the required and preferred qualifications referenced above. The application reviewers will be relying on written application materials to determine which qualified applicants will advance in the recruitment process. We will notify selected applicants to participate further in the selection process directly. References will be requested of final candidates. All applicants will be notified after the search is complete and a candidate has been selected.

Contact Information:
Cody Roekle,

Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Institutional Statement on Diversity:
Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.

The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.

For more information on diversity and inclusion on campus, please visit:Diversity and Inclusion

The University of Wisconsin-Madison is an Equal OpportunityEmployer.

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgroundsand encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, click here.

To request a disability or pregnancy-related accommodationfor any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR)in the division you are applying to.Please make your request as soon as possible to help the university respond most effectively to you.

Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment.

The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).

The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
**Job Summary**
We have an exciting opportunity for a Specialist, Global Computer Validation Quality Assurance for Corporate located remotely.
Provide quality assurance monitoring and audits of Charles River computer validation projects globally to assure compliance with applicable regulations, corporate policies, and procedures. Review and approve global technology processes and assist in periodic assessments of globally controlled IT regulated activities.
Essential responsibilities:
+ Communicate all identified compliance and quality risks to his/her supervisor.
+ Provide quality assurance monitoring of projects to assure regulatory compliance of complex and critical computer systems at designated sites, assisting with the development, review and approval of validation deliverables (e.g., validation plans, test results, and summary reports).
+ Provide compliance support to QA, operations, and project teams on multisite and global computer systems, assisting with the development, review and approval of system validation and maintenance lifecycle deliverables in compliance with company policies and procedures.
+ Develop, review and approve global policies, standards and procedures.
+ Assist in the development and maintenance of the computer validation training programs and present training in regulatory requirements for validation, maintenance, and operation of computer technologies.
+ Conduct audits of systems, vendors, information technology and processes for compliance with regulations and company procedures.
+ Work directly with the various staff and management on global internal audit-related activities including planning and oversight of IT internal and external audits, walkthroughs, testing, documentation of findings, issue remediation, follow-up, etc.
+ Maintain an up-to-date knowledge of computer validation requirements, practices and procedures, and inform other company staff of those requirements.
+ Provide compliance guidance to operational personnel on regulatory requirements for computerized system validation and data integrity.
+ Assist in conducting data integrity risk assessments and consult in risk mitigation strategies.
The pay range for this position is between $70,000.00 and $77,000.00 annually . Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
**Job Qualifications**
The following are minimum requirement related to the Specialist, Global Computer Validation Quality Assurance position.
+ _Education:_ Bachelor's degree (B.A./B.S.) or equivalent in a scientific discipline and/or computer related field.
+ _Experience:_ 5 or more years or related experience in a pharmaceutical, biotechnology and/or biomedical industry. Working knowledge of computer validation requirements in government regulations including FDA 21 CFR Parts 11, 58, 211, and 820, OECDs, data integrity guidance and related multinational industry standards and requirements.
+ _Certification/Licensure:_ None
+ _Other:_ Must be able to perform effectively as a team member, maintain a positive work atmosphere, communicate effectively, and interact in a professional manner with management, coworkers, and sponsors. Skill requirements include foresight, analysis and logic, systematic and orderly planning, and attention to detail.
**About Corporate Functions**
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.
**About Charles River**
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
**Equal Employment Opportunity**
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit

Role- Engineer - Software Quality Assurance & Validation (Medical Devices)
Location- Santa Clara, CA onsite
Job Type- Contract
Role Description:
We are seeking a highly skilled and experienced Engineer to join our team, focusing on the quality assurance and validation of non-product software used in medical device development. The successful candidate will be instrumental in ensuring that our software systems adhere to stringent regulatory standards and industry best practices, contributing directly to the safety and efficacy of our medical devices.
Key Responsibilities:

• Develop, implement, and maintain robust software quality assurance processes specifically for non-product software used in the medical device development lifecycle.
• Ensure strict adherence to relevant regulatory standards, including FDA regulations, ISO 13485, and IEC 62304, as well as industry best practices for non-product software.
• Provide comprehensive support during audits and inspections conducted by regulatory bodies, ensuring all non-product software systems meet required quality and documentation standards.
• Verify that all computerized systems are appropriately validated, including assessing the applicability and criticality of GxP and 21 CFR Part 11 requirements.
• Create and meticulously review a range of validation deliverables, which include but are not limited to:
  • Requirement Specifications (User, Functional)
  • Validation Plans
  • Qualification Protocols (Installation, Operational, Performance)
  • Reports (Summary, Exception) of protocol execution
  • Traceability Matrices
  • Periodic Review documentation
  • System Retirement/Decommissioning documentation

• Execute dry runs and test protocol runs to ensure accuracy and completeness.
• Conduct periodic reviews of systems to confirm their validated state and initiate appropriate corrective actions as needed.
• Oversee and perform the system retirement/decommissioning process for systems no longer in business use.
• Collaborate closely with software development and IT teams to establish and promote best practices for quality and compliance in all software-related activities.
• Offer expert guidance and support on quality assurance processes for non-product software, fostering robust software management throughout its lifecycle.
• Champion continuous improvement initiatives within software development processes, ensuring seamless alignment with the company's overarching quality management system.

Competencies:

• EIS: Medical Device & Regulations

Experience (Years): 4-6 years
Essential Skills:

• Minimum of a Bachelor's Degree in Engineering, Science, or a related technical field.
• Minimum of 4-5 years of hands-on experience in software quality assurance or software validation, with a strong preference for experience within the medical device industry.
• Demonstrated strong understanding of quality standards and regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and IEC 62304.
• Proven experience with non-product software validation, encompassing tools used for development, testing, and maintenance.

Desirable Skills:

• Good knowledge and practical experience with Computer System Validation (CSV) activities, including but not limited to:
  • GxP and 21 CFR Part 11 applicability/criticality assessment.
  • Identification, preparation, and review of validation deliverables such as Requirements, Plans, Protocols, Test specifications, Reports, Traceability Matrices, etc.
  • Execution of Dry/Test protocols.
  • Conducting Periodic Reviews of systems.
  • Performing System Retirement for systems no longer in business.

• Understanding of Medical Device Quality and Compliance principles.
• Good knowledge of GxP, GAMP, and 21 CFR Part 11 guidelines.
• Working experience with Product Lifecycle Management (PLM) tools.
• Sound knowledge of computer system development lifecycles.
• Knowledge of JIRA, JAMA software, and test automation is a plus.

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Position

As the Director, IT Computer System Validation & Quality Assurance, you will play a pivotal role in ensuring the compliance, reliability, and quality of our computer systems within the biotechnology domain. This position offers a unique opportunity for an experienced professional to lead and make a significant impact on our company's success.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Millbrae, CA office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

The ideal candidate for this role should possess experience in computer system validation and quality assurance within the biotech or pharmaceutical industry and demonstrate in-depth knowledge of regulatory requirements such as FDA and GxP pertaining to computer system validation and quality assurance. Proficiency in writing validation documentation, along with exceptional analytical and problem-solving skills, is essential. Strong leadership and communication skills are also critical for providing leadership to the Quality Assurance team and ensuring compliance with industry standards and regulatory demands in computer system validation and quality assurance.

What You'll Do

* Define and drive the global strategy for CSV and software QA aligned with regulatory standards and company goals.
* Establish governance for validation lifecycle management, including system risk assessments, validation planning, testing, and periodic reviews.
* Collaborate with IT, Clinical, and Regulatory teams to ensure compliant and robust software systems.
* Own and evolve the organization's CSV framework across GxP and non-GxP systems.
* Ensure that validation activities meet regulatory and business requirements for systems like Veeva Vaults, QMS, Safety systems and custom applications
* Develop and execute strategies for the validation of computer systems, ensuring compliance with industry standards, regulatory requirements, and company policies.
* Establish and maintain validation protocols, including test scripts, plans, and reports.
* Provide leadership and direction to the Software Quality Assurance team, fostering a culture of quality excellence.
* Collaborate with cross-functional teams to ensure that computer systems meet quality standards and perform efficiently.
* Create, review, and maintain comprehensive documentation related to computer system validation activities.
* Prepare validation reports and documentation for regulatory submissions and audits.
* Design and oversee the execution of test cases to verify the functionality and performance of computer systems.
* Identify and document deviations, issues, and discrepancies encountered during testing.
* Identify opportunities for process optimization and efficiency improvements in computer system validation and quality assurance.
* Develop and deliver training programs for relevant stakeholders.
* Stay current with industry regulations and standards related to computer system validation and quality assurance.
* Ensure audit readiness for internal and external inspections (e.g., FDA, EMA, etc.).
* Assist in regulatory inspections and audits as required.

Qualifications

* Post Graduate degree with 10+ years of experience or a bachelor's degree with 12+ years of experience in Computer Science, Information Technology, Engineering, or a related field. Master's degree is a plus.
* A minimum of 10+ years of experience in computer system validation and quality assurance within the biotech or pharmaceutical industry.
* In-depth knowledge of regulatory requirements (FDA, GxP, GAMP, etc.) related to computer system validation and quality assurance.
* Strong experience with CSV in GxP environments, including risk-based validation approaches.
* Experience working with Veeva Development Cloud Vaults and Commercial solutions
* Familiarity with software development methodologies (Agile, Waterfall, V-model).
* Proficiency in writing validation documentation, including protocols, reports, and procedures.
* Exceptional analytical and problem-solving skills with meticulous attention to detail.
* Strong leadership and communication skills, with the ability to collaborate effectively with cross-functional teams.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

* 401k plan with company matching
* Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
* Mental health and wellness benefits
* Weeklong summer and winter holiday shutdowns
* Generous paid time off and holiday policies
* Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
* Enhanced parental leave benefit
* Daily subsidized lunch program when on-site

The expected salary range for this role is $195,000 to $212,800 depending on skills, competency, and the market demand for your expertise.

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.