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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Principal Computer System Validation Specialist
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Purpose & Scope
The Computer System Validation (CSV) Lead is responsible for developing, executing, and maintaining the validation strategy for GxP-regulated computerized systems supporting manufacturing, laboratory, and quality operations. This role ensures that all systems comply with applicable regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5, and that validation deliverables are developed in alignment with corporate and industry best practices.
Role and Responsibilities
- Lead the planning and execution of validation projects for GxP computerized systems (manufacturing, laboratory, and quality).
- Author and/or review CSV deliverables including Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications (FS), Design Qualification (DQ), IQ/OQ/PQ protocols, and summary reports.
- Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable company SOPs and policies.
- Collaborate with cross-functional teams (IT, QA, Manufacturing, Lab, and vendors) to define validation scope, strategy, and deliverables.
- Lead impact assessments for software upgrades, patches, and configuration changes; ensure continuous validation state is maintained.
- Support data integrity initiatives and periodic review programs.
- Manage audit readiness for all validated systems; support internal and external inspections (FDA, EMA, MHRA, etc.).
- Develop and maintain validation templates, SOPs, and training programs.
Required Qualifications
- Bachelor’s degree in computer science, Engineering, Life Sciences, or related discipline.
- Minimum 5–8 years of experience in computer system validation or IT quality compliance within the pharmaceutical or biotech industry.
- Deep understanding of GxP Principals, GAMP 5 lifecycle methodology, and 21 CFR Part 11 / Annex 11 compliance.
- Experience leading validation of enterprise and laboratory systems such as LIMS, MES, QMS, ERP, or data historians (e.g., OSI PI, Empower, SAP, LabWare, etc.).
- Strong technical writing and documentation skills with attention to detail.
- Proven ability to manage multiple projects and priorities in a fast-paced, regulated environment.
Preferred Qualifications
- Master’s Degree (MBA, MIS, or related field)
- Experience with cloud-based or SaaS GxP systems
- Familiarity with data integrity, cybersecurity, and IT infrastructure qualification (IQ of servers, networks, virtualization).
- Project management or Lean Six Sigma certification .
Location and Working Environment
This position is based in Westborough, MA. Remote work from anywhere in the US is available.
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
Values: Innovation, Integrity and Impact sit at the heart of what we do.
Behaviors: We come together as ‘One Astellas’ , working with courage and a sense of urgency . We are outcome focused and consistently take accountability for our personal contribution.
Salary Range
$105,280-$150,400 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)
Benefits:
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Company fleet vehicle for eligible positions Referral bonus program
#LI-TR1
Principal Computer System Validation Specialist
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Purpose & Scope
The Computer System Validation (CSV) Lead is responsible for developing, executing, and maintaining the validation strategy for GxP-regulated computerized systems supporting manufacturing, laboratory, and quality operations. This role ensures that all systems comply with applicable regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5, and that validation deliverables are developed in alignment with corporate and industry best practices.
Role and Responsibilities
- Lead the planning and execution of validation projects for GxP computerized systems (manufacturing, laboratory, and quality).
- Author and/or review CSV deliverables including Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications (FS), Design Qualification (DQ), IQ/OQ/PQ protocols, and summary reports.
- Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable company SOPs and policies.
- Collaborate with cross-functional teams (IT, QA, Manufacturing, Lab, and vendors) to define validation scope, strategy, and deliverables.
- Lead impact assessments for software upgrades, patches, and configuration changes; ensure continuous validation state is maintained.
- Support data integrity initiatives and periodic review programs.
- Manage audit readiness for all validated systems; support internal and external inspections (FDA, EMA, MHRA, etc.).
- Develop and maintain validation templates, SOPs, and training programs.
Required Qualifications
- Bachelor’s degree in computer science, Engineering, Life Sciences, or related discipline.
- Minimum 5–8 years of experience in computer system validation or IT quality compliance within the pharmaceutical or biotech industry.
- Deep understanding of GxP Principals, GAMP 5 lifecycle methodology, and 21 CFR Part 11 / Annex 11 compliance.
- Experience leading validation of enterprise and laboratory systems such as LIMS, MES, QMS, ERP, or data historians (e.g., OSI PI, Empower, SAP, LabWare, etc.).
- Strong technical writing and documentation skills with attention to detail.
- Proven ability to manage multiple projects and priorities in a fast-paced, regulated environment.
Preferred Qualifications
- Master’s Degree (MBA, MIS, or related field)
- Experience with cloud-based or SaaS GxP systems
- Familiarity with data integrity, cybersecurity, and IT infrastructure qualification (IQ of servers, networks, virtualization).
- Project management or Lean Six Sigma certification .
Location and Working Environment
This position is based in Westborough, MA. Remote work from anywhere in the US is available.
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
Values: Innovation, Integrity and Impact sit at the heart of what we do.
Behaviors: We come together as ‘One Astellas’ , working with courage and a sense of urgency . We are outcome focused and consistently take accountability for our personal contribution.
Salary Range
$105,280-$150,400 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)
Benefits:
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Company fleet vehicle for eligible positions Referral bonus program
#LI-TR1
See All 6 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
- Electronics & Hardware
- 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, Astellas, and Rees Scientific, based on current listings on Migrate Mate as of August 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?
Boston, Waltham, 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 67% of validation specialist openings tied to Massachusetts are remote or hybrid as of August 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 6 Validation Specialist Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
Find Validation Specialist Jobs