3,877 Process Validation jobs in the United States

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
The Process Validation Engineer II is part of the Technical Operations Department located in Fargo, ND and will be on-site. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Process Validation team and report to the Process Validation Manager responsible for leading & supporting internal and external validation projects.
In this role, you will have the opportunity to:
+ Develop and review validation documents for facilities, equipment, and processes.
+ Ensure all documents comply with corporate standards and regulatory requirements.
+ Collaborate on experiments for new or modified manufacturing processes and equipment.
+ Analyze critical data and provide informed recommendations.
+ Support all phases of the validation life cycle, including research, development, and continuous monitoring.
The essential requirements of the job include:
+ Bachelor's degree in Engineering or Scientific field (preferably Chemical, Biology, or Microbiology) and 4+ years of experience in process development and/or technology transfer OR Associate degree in Engineering Technology or related field with 6+ years of process development experience in a life sciences company
+ Knowledge of regulatory and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices.
It would be a plus if you also possess previous experience in:
+ Authoring, executing, and summarizing process validation lifecycle documents for stages 1, 2, and 3.
+ Technical writing involving quality investigations, root cause analysis, and risk assessment.
#LI-KP1
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here ( .
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: or .

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
Summer Internship Program
The program is a 12-week paid internship immersive experience that provides functional learning working on robust and challenging project work, Executive and Senior leadership engagement, and exposure to Danaher Business System fundamentals. The program culminates with a report-out presentation to leaders from the organization. After successful completion of the program, interns will be considered to return as a full-time associate upon graduation.
This position is part of the Process Validation department located Fargo, ND and will be onsite working 40 hours per week . At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Technical Operations team and report to the Manager, Process Validation,
The Process Validation Intern for Aldevron is responsible assisting with the development, protocol generation, execution, and summary reports of internal and external validation initiatives. In this role, you will get exposure to the basic principles of Process Validation, Quality by Design, regulatory guidances that govern GMP manufacturing, and basic laboratory principles. This role will also help support other Validation programs and systems, including CAPA, laboratory investigations, and change management.
The essential requirements of the job include:
+ Currently pursuing a bachelor's degree in biology, biochemistry, chemical engineering, microbiology, or related scientific discipline
+ Previous experience working in a lab setting
+ Ability to follow standard operating procedures (SOP's)
It would be a plus if you also possess previous experience in:
+ Exposure to validation principles such as installation/operational qualification, process development/validation, or Quality by Design.
The hourly range for this role is $25-30. This is the rate that we in good faith believe is the rate of compensation for this role at the time of this posting.
When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System ( tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here ( .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
If you've ever wondered what's within you, there's no better time to find out.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here ( .
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: or .

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
At **Bristol Myers Squibb** we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
The **Senior Specialist, Associate Process Validation Engineer, Cell Therapy** provides process validation support to the Devens Cell Therapy Facility (CTF). The Senior Specialist participates in facility and process validation activities, including process tech transfers and lifecycle management.
**Shifts Available:**
Monday - Friday, Standard Working Hours
**Responsibilities:**
+ Responsible for oversight of CTF Process Validation activities including, but not limited to Process Performance Qualifications (PPQ), Capacity Increases (Ramps), Tech Transfers, and other Lifecycle Management changes.
+ Performs data analysis, including the use of statistics, and prepares written protocols/reports/summaries supporting validation studies.
+ Leads/Owns site Change Controls
+ Supports equipment and facility commissioning, qualification and validation.
+ Participates in facility and process risk assessments and authors qualification/ validation documents (e.g. procedures, protocols and reports) in accordance with internal and external regulatory expectations.
+ Supports investigations and global change controls as required.
+ Ensures safe and compliant cGMP operations, maintains permanent inspection readiness, and actively supports regulatory inspections.
+ Supports continuous improvements that reduce safety risks, operational costs, lead times, scrap, and discrepancy rates across all aspects of production.
+ Serves as a MS&T representative on cross-functional and multi-site teams
+ Maintains effective collaborative relationships across the site and network
**Knowledge and Skills:**
+ Experience in cGMP's and multi-national biopharmaceutical/cell therapy regulations
+ Experience in facility/clean room design, process, equipment, automation, and validation.
+ Experience with internal and health authority audits
+ Excellent verbal/written communication skills
**Basic Requirements:**
+ Knowledge of science generally attained through studies resulting in a Bachelor's degree in science, engineering, biochemistry or related discipline, or its equivalent is required
+ A minimum of 2 years' experience in biopharmaceutical operations, or its equivalent is required
**BMSCART**
**#LI-ONSITE**
**GPS_2025**
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Compensation Overview:**
Devens - MA - US: $87,660 - $106,224
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :05:56.234 UTC
**Location:** Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

The Senior Manager for End-to-End Process Validation & Technical Regulatory Liaison is accountable for leading the strategy and execution of global process validation activities across the vaccine drug substance portfolio. This role owns the planning, execution, and lifecycle management of process validation, ensuring compliance with regulatory expectations and industry best practices.

The Senior Manager provides leadership for cross-functional validation programs spanning polysaccharides, carrier proteins, conjugation, drug substance intermediates and drug product. This role is also accountable for authoring and reviewing regulatory documentation to support successful global filings, health authority interactions, and lifecycle management of commercialized products.

The position reports into the Senior Director for Global Process Validation and will collaborate on overall program strategy, with primary responsibility and accountability for validation strategy and regulatory deliverables.
Essential Functions:

• End-to-End Process Validation
  • Lead strategy and execution of process validation, including process design, qualification, and continued verification.
  • Drive alignment with global health authority requirements (FDA, EMA, PMDA, etc.) for validation programs across multiple modalities.
  • Ensure technical robustness of validation approaches through risk assessments, process characterization, and CPV implementation.
• Regulatory Documentation
  • Author and critically review regulatory submissions (INDs, BLAs/MAAs, supplements, responses to information requests, and briefing packages).
  • Translate complex technical data into clear, concise regulatory documentation aligned with global health authority expectations.
  • Serve as technical liaison with Regulatory Affairs to ensure timely and high-quality submissions.
• Cross-Functional Leadership
  • Partner with MSAT, Process Development, Quality, Supply Chain, and Regulatory to ensure seamless execution of validation and regulatory deliverables.
  • Provide strategic input during technology transfers, lifecycle changes, and introduction of new manufacturing sites.
  • Support responses to health authority queries and participation in regulatory inspections.
• Process Robustness & Lifecycle Management
  • Establish systems to monitor, trend, and improve process performance across the product lifecycle.
  • Lead technical assessments for process changes and comparability evaluations to maintain product quality and supply continuity.
  • Identify and implement best practices for sustaining process robustness and compliance.
• Data Management
  • Acquire and gather data from manufacturing nodes throughout the supply chain to enable regulatory filings, process monitoring, and continuous improvement.
  • Support data verification for all commercial regulatory submissions.
• Communication & Leadership
  • Communicate process validation strategy and outcomes effectively to senior leadership, regulatory bodies, and external partners.
  • Build and develop a high-performing team with expertise in validation and regulatory documentation.
  • Foster a culture of compliance, scientific rigor, and operational excellence.
• Travel - 10-20% travel required to global manufacturing sites and regulatory interactions.

Requirements:

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with minimum of 8+ years of relevant experience.
• Demonstrated leadership in process validation, CPV, and regulatory submissions in a biologics or vaccine environment.
• Broad technical knowledge across biologics processes (fermentation, purification, conjugation, formulation).
• Proven experience authoring high-quality regulatory submissions and supporting health authority interactions.
• Strong organizational, problem-solving, and strategic planning skills.
• Excellent written and verbal communication skills with the ability to convey complex scientific concepts clearly.
• Demonstrated ability to proactively identify risks and implement mitigation strategies.
• Track record of building and mentoring teams to achieve collective goals.

Reports to: Senior Director, Process Validation

Location: San Carlos, CA

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $158,000 - $184,000 (SF Bay Area). Salary ranges for non-California locations may vary.

Relocation:

This role is not eligible for relocation assistance.

We are 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 veteran status.

Regeneron is currently looking for a Principal/ Staff Process Controls & Validation Engineer for the Labeled Drug Product fill/finish manufacturing processes. This is Monday-Friday, 8am-4:30pm schedule. Process Sciences is a technical services department that deals with a range of scientific, technical, engineering, and mathematical needs from the laboratory to the manufacturing floor. This role provides technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.
As a Principal/Staff Process Controls & Validation Engineer **,** a typical day might include the following:
+ Provides technical support to a variety of activities such as technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities.
+ Evaluates product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities.
+ Analyzes information and data from development through late stage-characterization as well as at-scale manufacturing history.
+ Liaises with other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle.
+ Authors protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge.
+ Ensures alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines.
+ Provides support to audits/inspections and drafting of CMC sections of regulatory submission as needed.
+ Applies engineering principles to the development and execution of process controls and validation strategies.
+ Analyzes data using a combination of statistics, engineering principles and other techniques to gain insights into manufacturing process performance and control.
+ Develops and monitors health of the business using key performance indicators.
+ Develops and improves cross-functional business and manufacturing processes.
+ Works effectively and efficiently in a team-oriented environment.
+ Provides support to laboratory studies and/or studies performed at manufacturing scale.
This role might be for you if you:
+ Can perform advanced problem solving including addressing ambiguous issues and situations.
+ Can accurately scope projects - break down work into process steps, develop schedules and tasks, identify, interpret, and communicate risk (process management, measuring & managing work).
+ Can deal with changing priorities and are able to adapt to change.
+ Can use technical expertise to influence a non-technical audience on a path forward.
To be considered for Principal Process Controls & Validation Engineer you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in Engineering; Biomedical engineering, Chemical Engineering preferred. For various levels you must have the following:
+ Principal Process Controls & Validation Engineer: 8+ years in Drug Product/Labeled Drug Product
+ Staff Process Controls & Validation Engineer 10+ years in Drug Product/Labeled Drug Product
+ Or equivalent combination of education& experience in Drug Product/Labeled Drug Product
Experience in aseptic processing, drug product development, labeled drug product processing, or biopharmaceutical/combination product validation is required.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**Salary Range (annually)**
$90,800.00 - $173,400.00

**Description**
Boehringer Ingelheim is currently seeking a talented and innovative Intern to join our _MSAT Process Validation_ department located at our _Fremont_ facility. As a Co-op student, you will _generate validation documents (protocols/reports) and support execution of validation studies (lifetime, mixing validation, etc.). In addition, you will also support Continued Process Verification (CPV) program for various products at Fremont Biopharma facility including setup parameters for process monitoring in CPV software, update Control Strategy Summary and support protocol/report generation_ _._
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees
**Duties & Responsibilities**
+ _Responsible for validation documents (protocols/reports) and support execution of validation studies_ _(lifetime, mixing validation, etc.)_
+ _Support client and site audit activities as required_
+ _Responsible for setup trending parameters in CPV software, printing trending reports, identifying trend signals and facilitate expert meetings_
**Requirements**
+ Must be a current undergraduate, graduate or advanced degree student in good academic standing
+ Student must be enrolled at a college or university for the duration of the internship
+ Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred
+ Major or minor in related field of internship
+ Undergraduate students must have completed at least 12 credit hours at current college or university
+ Graduate and Advanced Degree students must have completed at least 9 credit hours at current college or university
**Desired Experience, Skills and Abilities:**
+ _Knowledge in Process Validation and CPV is preferred._
+ _Experience with planning and generating validation protocols and reports._
+ _Excellent technical writing and verbal communication skills._
+ _Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision._
**Compensation Data**
This position offers a base salary typically between (20.00) and (33.00).  There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here. ( qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

#2531 Validation Engineer - Pharmaceutical

Our client is a Fortune 500 Pharmaceutical Company with Global reach. They are currently looking for a strong Validation Engineer to join their tenured Validation team.

Key responsibilities for this role include:

• Provide direction, reviews and provides Quality approval for design qualification documents, validation protocols, summary reports, discrepancy reports and CPV reports.
• Provides the Quality Assurance review and approval of Engineering, Calibration, Facility Maintenance, Production Support (Maintenance), Technical Services and IT procedures and forms.
• Authors protocols and reports as required/assigned.
• Perform validation planning and tracking.
• Assist in the development and maintenance of the procedures defining the validation program at MTI.
• Participates in the evaluation of changes to validated systems to ensure the validate state is maintained. Provides direction, reviews and approves proposed changes and facilitates decision making regarding the extent of any re-validation requirements.
• Assist in the compilation of periodic reports required by the validation program.

The minimum qualifications for this role are:

• Bachelor of Science degree (or equivalent) and 7 + years in a pharmaceutical cGMP environment is required. A combination of experience and/or education will be taken into consideration.
• Must possess a working knowledge of Pharmaceutical validation and cGMP concepts.