Validation Specialist Jobs in Massachusetts
Validation Specialist jobs in Massachusetts are consistently in demand, concentrated in the life sciences, pharmaceutical manufacturing, and medical device sectors that define the state's economy, with openings at every level from entry-level validation technician through senior validation engineer. The greatest hiring activity sits in the greater Boston area, the Route 128 corridor, and Worcester, where established employers like Pfizer, Takeda, and Boston Scientific maintain large validation and quality teams. Computer system validation, process validation, and equipment qualification are the specialties drawing the most consistent interest from Massachusetts hiring managers. Find a role that fits below and apply directly.
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Showing 4 of 7+ Validation Specialist jobs
INTRODUCTION
ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.
THE ROLE:
ElevateBio is looking for a Lead QAV Specialist to provide QA oversight for the BaseCamp Waltham Commissioning, Qualification, and Validation activities. In this role the Lead will be responsible for managing cGMP compliance from a Quality Assurance perspective of validation master plans, project validation plans, facility commissioning/qualification, utility commissioning/qualification, process equipment qualification, and lab equipment and instrument qualification. In addition, this position will support all risk assessments, technical reports, change controls, deviations and CAPAs related to commissioning, qualification, and validation activities. The candidate will contribute to a team-based collaborative environment promoting commitment to continuous improvement and achievement of goals within the QAV group.
HERE'S WHAT YOU'LL DO:
- Leads QA partnership for operational activities for Engineering groups (i.e. commissioning, qualification, and validation activities to the GMP manufacturing facility and quality control laboratories). Recognized as quality expert for these programs and acts as direct escalation pathway for teams.
- Leads QA oversight of quality events for ongoing validation and engineering operations (equipment upgrades, deviations, and related CAPAs). Scope inclusive of manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
- Independently evaluates CQV change controls by authoring impact assessments and provides QA support and approval for associated CQV activities.
- Leads QA oversight for CMMS, collaborates with Engineering and Lab and Site Services to evaluate Quality impact for database modification requests.
- Liaise with project teams to develop project schedules, escalate issues, track milestones, and ensure adherence to program timelines.
- Potential to provide administration support for Kneat electronic validation system.
- Leads QA oversight and support for periodic review and requalification activities.
- Manage team of QAV personnel including both FTE and contractor resources.
- QA SME for Equipment Relocation program, supports all relocation activities that arise due to ongoing manufacturing needs.
REQUIREMENTS
- Bachelor's degree and at least 5 years of related experience; or Master's degree with at least 3 years of related experience; or a PhD with up to 1 year of related experience.
- Strong knowledge of 21 CFR, ICH, EU regulations.
- Prior experience in Cell and Gene Therapy manufacturing a plus.
- Prior management experience a plus.
- Experience in new facility commissioning and qualification preferred.
- Experience with Blue Mountain CMMS system desired.
- Strong technical writing skills and proficiency in various computer programs (Word, Excel, PowerPoint, Kneat, Veeva, Blue Mountain CMMS).
- Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.
- A team player, who listens effectively and invites response and discussion.
- A collaborator who communicates in an open, clear, complete, timely and consistent manner.
PHYSICAL AND ENVIRONMENT REQUIREMENTS:
- Ability to stand, walk, bend and stretch for extended period of time.
- Ability to lift 15-20 lbs.
- Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
- Ability to perform routine repetitive motions with use of arms, wrists and hands.
COMPENSATION
- The budgeted range for this position is $50/hour - $69/hour. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
INTRODUCTION
ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.
THE ROLE:
ElevateBio is looking for a Lead QAV Specialist to provide QA oversight for the BaseCamp Waltham Commissioning, Qualification, and Validation activities. In this role the Lead will be responsible for managing cGMP compliance from a Quality Assurance perspective of validation master plans, project validation plans, facility commissioning/qualification, utility commissioning/qualification, process equipment qualification, and lab equipment and instrument qualification. In addition, this position will support all risk assessments, technical reports, change controls, deviations and CAPAs related to commissioning, qualification, and validation activities. The candidate will contribute to a team-based collaborative environment promoting commitment to continuous improvement and achievement of goals within the QAV group.
HERE'S WHAT YOU'LL DO:
- Leads QA partnership for operational activities for Engineering groups (i.e. commissioning, qualification, and validation activities to the GMP manufacturing facility and quality control laboratories). Recognized as quality expert for these programs and acts as direct escalation pathway for teams.
- Leads QA oversight of quality events for ongoing validation and engineering operations (equipment upgrades, deviations, and related CAPAs). Scope inclusive of manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
- Independently evaluates CQV change controls by authoring impact assessments and provides QA support and approval for associated CQV activities.
- Leads QA oversight for CMMS, collaborates with Engineering and Lab and Site Services to evaluate Quality impact for database modification requests.
- Liaise with project teams to develop project schedules, escalate issues, track milestones, and ensure adherence to program timelines.
- Potential to provide administration support for Kneat electronic validation system.
- Leads QA oversight and support for periodic review and requalification activities.
- Manage team of QAV personnel including both FTE and contractor resources.
- QA SME for Equipment Relocation program, supports all relocation activities that arise due to ongoing manufacturing needs.
REQUIREMENTS
- Bachelor's degree and at least 5 years of related experience; or Master's degree with at least 3 years of related experience; or a PhD with up to 1 year of related experience.
- Strong knowledge of 21 CFR, ICH, EU regulations.
- Prior experience in Cell and Gene Therapy manufacturing a plus.
- Prior management experience a plus.
- Experience in new facility commissioning and qualification preferred.
- Experience with Blue Mountain CMMS system desired.
- Strong technical writing skills and proficiency in various computer programs (Word, Excel, PowerPoint, Kneat, Veeva, Blue Mountain CMMS).
- Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.
- A team player, who listens effectively and invites response and discussion.
- A collaborator who communicates in an open, clear, complete, timely and consistent manner.
PHYSICAL AND ENVIRONMENT REQUIREMENTS:
- Ability to stand, walk, bend and stretch for extended period of time.
- Ability to lift 15-20 lbs.
- Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
- Ability to perform routine repetitive motions with use of arms, wrists and hands.
COMPENSATION
- The budgeted range for this position is $50/hour - $69/hour. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
See All 7 Validation Specialist Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
Find Validation Specialist JobsValidation Specialist Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Validation Specialist Job Market in Massachusetts
A snapshot from current Massachusetts openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Consulting & Professional Services
What Massachusetts Employers Look For
The qualifications that appear most often in validation specialist jobs across Massachusetts.
- Bachelor's degree in life sciences, engineering, chemistry, or a closely related field
- Hands-on experience with FDA-regulated validation protocols and GMP environments
- Proficiency writing IQ, OQ, and PQ documentation to 21 CFR Part 11 standards
- Familiarity with computer system validation frameworks such as GAMP 5
- Experience supporting audits and preparing validation summary reports for regulatory review
- Strong working knowledge of risk assessment tools including FMEA and hazard analysis
Validation Specialist Jobs in Massachusetts: Frequently Asked Questions
How do you become a validation specialist in Massachusetts?
Most Massachusetts employers require a bachelor's degree in engineering, chemistry, biology, or a related life sciences field as the foundation for entering validation work. There is no state-issued license specific to validation specialists, but the role is heavily regulated through FDA frameworks, so demonstrating familiarity with GMP, 21 CFR Part 11, and validation lifecycle documentation is essential. Certifications such as the Certified Quality Engineer or Pharmaceutical Validation Professional credential add meaningful credibility with Massachusetts pharmaceutical and biotech hiring managers.
How much do validation specialists make in Massachusetts?
Validation specialists in Massachusetts earn a median of about $109,420 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $81,960 for the lowest 10% to over $161,870 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire validation specialists in Massachusetts?
Employers hiring validation specialists in Massachusetts right now include Katalyst Healthcares & Life Sciences, ElevateBio, and Merck KGaA, based on current listings on Migrate Mate as of October 2026. Massachusetts's dense concentration of pharmaceutical manufacturers, contract research organizations, and medical device companies means validation roles surface regularly across a wide range of employer sizes, from global corporations to mid-size biotech firms along the Route 128 corridor.
Which Massachusetts cities have the most validation specialist jobs?
Waltham, Boston, and Cambridge have the most validation specialist openings in Massachusetts. Greater Boston anchors the majority of postings given its dense cluster of pharmaceutical headquarters, biotech campuses, and medical device manufacturers, while Worcester and nearby suburban corridors along Route 128 generate consistent openings tied to large manufacturing and quality operations established there.
Are there remote validation specialist jobs in Massachusetts?
Yes, but they're rare. About 33% of validation specialist openings tied to Massachusetts are remote or hybrid as of October 2026, reflecting the hands-on nature of most validation work. Execution phases such as equipment qualification, process validation runs, and on-site audits require physical presence, though documentation-heavy roles like protocol writing, regulatory writing, and computer system validation occasionally allow flexible or partially remote arrangements.
How can I get hired as a validation specialist in Massachusetts with little or no experience?
The most realistic entry path is a quality associate or validation technician role at a Massachusetts contract manufacturing organization, where onboarding programs are structured to train candidates who hold a relevant degree but lack direct validation experience. Large employers like MilliporeSigma and Thermo Fisher Scientific run rotational and new-graduate associate programs at their Massachusetts sites. Moving laterally from adjacent roles in quality control, analytical laboratory work, or manufacturing operations is also common, and completing a GAMP 5 or GMP fundamentals course before applying strengthens a candidate's profile noticeably.
Where can I find and apply to validation specialist jobs in Massachusetts?
You can find and apply to validation specialist jobs in Massachusetts on Migrate Mate, which lists current Massachusetts openings across the pharmaceutical, biotech, and medical device sectors. Find the roles that match your experience and apply directly without creating an account or signing up.
See All 7 Validation Specialist Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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