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Contract Validation Engineer Jobs in Massachusetts

Sebela Pharma

CQV/Validation Engineer

Holbrook, MA · On-site

$33 - $43/hr

Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has its contract development and ... The CQV/Validation Engineer is responsible for supporting the activities required to implement the ...

Arthur Lawrence

Be Seen First

Junior Validation Engineer - CSV/CQV

Cambridge, MA · On-site

$30 - $32/hr

We are seeking a Junior Validation Engineer to support validation, calibration, and qualification ... Opportunity for permanent employment following the initial contract period. Apply today if you are ...

New

Valspec

Process Validation Engineer

Boston, MA · On-site

$70 - $80/hr

Process Engineer -- Upstream / Downstream / Clean Utilities (Consultant) -- Contract Engagement ... Contract / consulting -- initial term approximately 12 months, with a possibility of extension ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA

$115K - $140K/yr

JOB SUMMARY The incumbent is responsible for leading computerized systems validation projects. This ... contract firms Essential The ability to report on project activity in a clear and concise manner ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA · On-site

$115K - $140K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Enhance CSV validation programs * Analyze validation data, identify gaps, and support ... contract firms Essential The ability to report on project activity in a clear and concise manner ...

Genezen

Sr. CSV Validation Engineer

Lexington, MA · On-site

$115K - $140K/yr

Enhance CSV validation programs * Analyze validation data, identify gaps, and support ... contract firms Essential The ability to report on project activity in a clear and concise manner ...

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How much do contract validation engineer jobs pay per hour?

As of Aug 12, 2026, the average hourly pay for contract validation engineer in Massachusetts is $56.79, according to ZipRecruiter salary data. Most workers in this role earn between $43.08 and $69.04 per hour, depending on experience, location, and employer.

What are the primary responsibilities of a contract validation engineer on a typical project?

A Contract Validation Engineer is primarily responsible for reviewing and verifying that project deliverables, processes, and products comply with contractual requirements and industry standards. This includes conducting thorough documentation reviews, performing technical validations, and collaborating with project managers, legal teams, and quality assurance professionals to resolve any discrepancies. You will also support audits, maintain compliance records, and participate in meetings to ensure all stakeholders remain informed and aligned. The role often involves both independent analysis and teamwork, providing an excellent environment for those who enjoy balancing technical expertise with cross-functional collaboration.

What are the key skills and qualifications needed to thrive in the contract validation engineer position, and why are they important?

To thrive as a Contract Validation Engineer, you need strong analytical skills, a degree in engineering or a related field, and a deep understanding of contract requirements and industry regulations. Proficiency with validation software, quality management systems (QMS), and relevant certifications such as Six Sigma or ISO standards is often preferred. Outstanding attention to detail, effective communication, and the ability to work collaboratively across departments are crucial soft skills. These competencies ensure accurate contract assessments, regulatory compliance, and seamless integration of contractual obligations into engineering projects.

What is a contract validation engineer?

A Contract Validation Engineer is responsible for ensuring that systems, processes, and products meet regulatory and contractual requirements. They typically work on a temporary or project basis, verifying compliance through testing, documentation, and analysis. Their role involves collaborating with engineering teams to validate designs, troubleshoot issues, and ensure quality standards are met. This position is common in industries like pharmaceuticals, aerospace, and manufacturing, where strict validation protocols are required.

What are the most commonly searched types of Validation Engineer jobs in Massachusetts? The most popular types of Validation Engineer jobs in Massachusetts are:
What are popular job titles related to Contract Validation Engineer jobs in Massachusetts? For Contract Validation Engineer jobs in Massachusetts, the most frequently searched job titles are:
What job categories do people searching Contract Validation Engineer jobs in Massachusetts look for? The top searched job categories for Contract Validation Engineer jobs in Massachusetts are:
What cities in Massachusetts are hiring for Contract Validation Engineer jobs? Cities in Massachusetts with the most Contract Validation Engineer job openings:
Contract Validation Engineer jobs near you
Infographic showing various Contract Validation Engineer job openings in Massachusetts as of August 2026, with employment types broken down into 80% Full Time, and 20% Contract. Highlights an 80% In-person, 10% Hybrid, and 10% Remote job distribution, with an average salary of $118,116 per year, or $56.8 per hour.

Principal BioPharma Manufacturing Validation Engineer

Astellas Pharma, Inc.

Westborough, MA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 16 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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