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Computer System Validation Jobs in Boston, MA (NOW HIRING)

Staffingine LLC

Data Warehouse BI Tester

Boston, MA · On-site

Extensive experience with pharma companies, including strong CSV (Computer System Validation) skills * Capable of executing both GxP and non-GxP programs/projects * Excellent communication skills ...

Genezen

Sr. System Administrator

Lexington, MA · On-site

$96K - $130K/yr

Install and upgrade computer components and software, manage virtual servers, and integrate automation processes per Computer System Validation SOPs and protocols * Ensure that the IT environment is ...

Syner-G

Validation Engineer

Boston, MA · On-site +1

Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation. * Hands-on equipment start-up and troubleshooting experience is highly desired. * Report writing experience ...

IT EXCEL LLC

Jr QA Tester

Cambridge, MA

$55K - $58K/yr

We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...

IT EXCEL LLC

Jr QA Tester

Cambridge, MA · On-site

$55K - $58K/yr

We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...

Syner-G

Validation Engineer

Boston, MA · On-site

Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation. * Hands-on equipment start-up and troubleshooting experience is highly desired. * Report writing experience ...

Syner-G

Validation Engineer

Boston, MA

Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation. * Hands-on equipment start-up and troubleshooting experience is highly desired. * Report writing experience ...

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Computer System Validation information

See Boston, MA salary details

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$59

$93

How much do computer system validation jobs pay per hour?

As of Aug 6, 2026, the average hourly pay for computer system validation in Boston, MA is $59.01, according to ZipRecruiter salary data. Most workers in this role earn between $45.43 and $70.00 per hour, depending on experience, location, and employer.

What are some typical challenges faced in computer system validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.

What is a computer system validation?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What are the key skills and qualifications needed to thrive in computer system validation, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring software and systems meet compliance standards such as GxP. It involves documentation, testing, and validation of computer systems, often requiring knowledge of regulatory requirements and validation tools. The field offers stable employment opportunities and career growth for professionals with technical skills and certifications like GAMP or 21 CFR Part 11 compliance.
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Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in Boston, MA as of July 2026, with employment types broken down into 1% As Needed, 83% Full Time, 13% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $122,729 per year, or $59 per hour.

Principal BioPharma Manufacturing Validation Engineer

Astellas Pharma, Inc.

Westborough, MA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 10 days ago

Job description

Principal BioPharma Manufacturing Validation Engineer
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 Principal Validation Engineer is a senior technical leader and Validation subject matter expert responsible for defining and executing an integrated, risk-based validation strategy to ensure facilities, utilities, equipment, computerized systems, cleaning, and manufacturing processes are qualified and maintained in a state of control to support Process Performance Qualification (PPQ), regulatory filing, licensure, and sustained commercial supply. This role provides strategic and hands-on leadership for PPQ planning and readiness, authorship and review of validation lifecycle deliverables, regulatory inspection readiness, and mentoring of junior team members across the organization.
Role and Responsibilities
  • Lead the site validation strategy and lifecycle execution for facilities, utilities, equipment, computerized systems, cleaning, and manufacturing processes to support PPQ, licensure, and sustained commercial operations.
  • Serve as the site Validation SME for PPQ planning and readiness, including validation strategy, risk assessments, protocols, summary reports, discrepancy resolution, and cross-functional execution support.
  • Provide guidance for commissioning and qualification of facilities/utilities, equipment, automated systems, process, and QC system validation, excluding method validation.
  • Review and approve validation documentation associated with capital projects for facilities, equipment, utilities, and QC equipment for GMP readiness and assist with resolving technical issues, evaluating results, and generating reporting documentation.
  • Manage contracted validation service providers to ensure company requirements are fulfilled through effective performance monitoring and established business agreements.
  • Collaborate cross-functionally, providing guidance in support of the continuous improvement, monitoring and sustaining validation practices and records.
  • Ensures impact to validation status for new systems and changes to existing systems are performed through science-based quality risk assessments.
  • Collaborate with Quality Assurance to ensure all qualification data and records are compiled, analyzed, and managed through effective processes and collaborate with site-based validation team members to provide guidance, assist to resolve issues/conflicts, and provide mentoring.
  • Ensure BOH data integrity requirements are incorporated in facilities/utilities, equipment, automated systems, process, and QC system validation activities.
  • Provide oversight for regulatory submission documentation to ensure timely licensure of new cell or gene therapy products in multiple regions and work closely with internal stakeholders, equipment providers, and capital project teams in support of the development of and subsequent qualifications and validations of facility and technical systems.

The Principal Validation Engineer independently leads capital validation projects and other complex, high-risk validation deliverables that directly impact PPQ readiness, regulatory filing and licensure milestones, inspection readiness, and sustained commercial operations. This role is responsible for managing schedule, budget, and technical scope for assigned validation activities; providing regular updates to key stakeholders; influencing cross-functional decisions that affect compliance and business continuity; and providing technical oversight for contract resources and external partners, including onboarding and offboarding decisions as needed. In addition, the Principal Validation Engineer plays a key role in strengthening the site validation program by providing SME input to standards, procedures, and practices, and by managing deliverables required to establish and maintain revalidation plans and the validated state of the site.
Required Qualifications
  • BS in Engineering or related discipline with 10+ years of direct validation engineering experience, or MS in Engineering or related discipline with 8+ years of direct validation engineering experience, in a GMP biopharmaceutical, biologics, cell therapy, or gene therapy manufacturing environment.
  • Demonstrated experience leading validation strategy and execution in support of Process Performance Qualification (PPQ), including readiness planning, risk assessments, protocol development, execution support, discrepancy resolution, and summary reporting.
  • Strong knowledge of risk-based commissioning, qualification, and validation for facilities, utilities, equipment, computerized systems, cleaning, and manufacturing processes in a commercial readiness environment.
  • Demonstrated experience preparing, reviewing, and/or providing strategic oversight of validation documentation that supports regulatory filings, licensure, health authority inspections, and ongoing inspection readiness.
  • Strong understanding of global GMP and regulatory expectations related to validation lifecycle management, data integrity, quality risk management, and maintenance of validated state.
  • Demonstrated leadership, critical thinking, and ability to influence cross-functional teams and senior stakeholders to achieve complex, high-impact milestones.
  • Proven ability to mentor and develop junior team members, provide technical guidance, and promote consistent, compliant validation practices across the organization.
  • Strong and effective problem-solving skills, with the ability to make sound, science-based decisions under pressure while maintaining quality, compliance, and business continuity.

Preferred Qualifications
  • Experience in a facility startup and licensure environment.
  • Experience working with quality systems in a commercial-ready gene therapy facility.
  • Must be self-motivated with ability to handle, organize and prioritize multiple tasks, maintain accountability and able to perform under pressure to meet production deadlines.
  • Ability to deal with ambiguity, creative and pragmatic approach to problem solving.
  • Exposure of regulatory authority inspections and inspection readiness.

Location and Working Environment
  • This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs
  • This is an on-site role working in a cGMP regulated manufacturing facility
  • On occasion, this role may travel to other Astellas manufacturing facilities (0-10%)

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
$119,000 - $170,000 (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

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