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Junior Validation Engineer Jobs (NOW HIRING)

Millstone

Senior Validation Engineer

Fall River, MA · On-site

Equipment and Process Validation: * Document and execute Installation Qualification (IQ ... Mentor junior engineers or technicians as needed. * Project Management (Depending on Position Level)

FITS LLC

Sr. Validation Engineer

Juncos, PR · On-site

Validation and Packaging Equipment AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job ... Provide technical guidance and mentorship to junior engineers and project team members. * Support ...

Lucid Motors

Sr. ADAS Validation Engineer

Newark, CA

We are currently seeking a Sr. ADAS Validation Engineer to join our Software Quality and Validation ... Mentor and guide junior team members Qualifications: * 4+ years of leading/owning the system ...

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$33.5K

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How much do junior validation engineer jobs pay per year?

As of Jun 11, 2026, the average yearly pay for junior validation engineer in the United States is $71,799.00, according to ZipRecruiter salary data. Most workers in this role earn between $48,500.00 and $80,000.00 per year, depending on experience, location, and employer.

What does a Junior Validation Engineer do?

A Junior Validation Engineer is responsible for assisting in the testing and verification of products, systems, or processes to ensure they meet specified requirements and standards. They typically work under the supervision of senior validation engineers and help develop validation protocols, execute tests, and document results. Their role is crucial in industries such as pharmaceuticals, manufacturing, and technology, where compliance and quality assurance are essential. Junior Validation Engineers also help identify issues and suggest improvements to enhance reliability and safety.

What are some typical challenges faced by a Junior Validation Engineer during project execution?

As a Junior Validation Engineer, you may encounter challenges such as understanding complex validation protocols, managing tight project timelines, and adapting to strict regulatory requirements. You'll often need to collaborate closely with cross-functional teams, including quality assurance, manufacturing, and engineering, to ensure validation processes are thorough and compliant. Developing a keen attention to detail and strong communication skills will help you effectively address these challenges and contribute to successful project outcomes.

What are the key skills and qualifications needed to thrive as a Junior Validation Engineer, and why are they important?

To thrive as a Junior Validation Engineer, you need a background in engineering or life sciences, strong analytical skills, and knowledge of regulatory standards like GMP. Familiarity with validation protocols, data analysis software, and documentation systems is typically required, and certifications such as Six Sigma or validation-specific training can be beneficial. Attention to detail, problem-solving, and effective communication are essential soft skills for collaborating with cross-functional teams and ensuring compliance. These skills and qualities are crucial for ensuring product quality, regulatory adherence, and the smooth execution of validation processes.

What is the difference between Junior Validation Engineer vs Validation Engineer?

AspectJunior Validation EngineerValidation Engineer
QualificationsTypically an entry-level degree (BSc or equivalent) in engineering, life sciences, or related fields; some certifications may be preferredHigher experience, often with professional certifications like CQE or CSQE
Work EnvironmentAssists in validation activities under supervision, often in regulated industries like pharmaceuticals or manufacturingLeads validation projects, responsible for planning and executing validation protocols independently
ResponsibilitiesPerforms routine validation tasks, documents results, supports senior staffDesigns validation strategies, reviews validation documentation, ensures compliance

The main difference between a Junior Validation Engineer and a Validation Engineer lies in experience and responsibility level. Junior Validation Engineers typically support validation activities under supervision, while Validation Engineers lead validation projects and make independent decisions. Both roles require knowledge of validation processes, but the Validation Engineer position demands more expertise and leadership in the field.

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Junior Validation Engineer jobs near you
Infographic showing various Junior Validation Engineer job openings in the United States as of June 2026, with employment types broken down into 92% Full Time, 4% Part Time, and 4% Contract. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $71,799 per year, or $34.5 per hour.

Principal BioPharma Manufacturing Validation Engineer

Astellas Pharma, Inc.

Westborough, MA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 13 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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