Process Validation Engineer

Job#: 3018307

Job Description:

Validation Engineer

Location: Andover, MA

Department: Quality / Validation

Reports To: Validation Manager

Position Summary

The Process Validation Engineer will be responsible for developing, executing, and maintaining validation activities for pharmaceutical manufacturing processes, with a primary focus on Skid filtration systems and Change Control management. This role ensures compliance with regulatory requirements (FDA, EMA, ICH) and internal quality standards, supporting robust and reliable production processes.

Key Responsibilities

• Validation Activities
  • Develop and execute validation protocols (IQ/OQ/PQ) for Skid filtration systems and associated equipment.
  • Perform risk assessments and establish critical process parameters for filtration processes.
  • Analyze validation data, prepare reports, and ensure timely approval of documentation.
• Change Control Management
  • Lead and manage change control processes related to equipment, processes, and systems.
  • Assess impact of proposed changes on validated state and regulatory compliance.
  • Collaborate with cross-functional teams to implement changes effectively and maintain GMP compliance.
• Compliance & Documentation
  • Ensure adherence to cGMP, FDA, EMA, and ICH guidelines for process validation.
  • Maintain accurate and complete validation documentation in accordance with company SOPs.
  • Support internal and external audits by providing validation evidence and responding to observations.
• Continuous Improvement
  • Identify opportunities for process optimization and validation lifecycle improvements.
  • Stay current with industry trends and regulatory updates related to process validation and filtration technologies.

Qualifications

• Education: Bachelor's degree in Engineering, Pharmaceutical Sciences, or related field (Chemical, Mechanical, or Biotech Engineering preferred).
• Experience:
  • 3+ years in pharmaceutical or biotech manufacturing with hands-on validation experience.
  • Strong knowledge of Skid filtration systems and sterile manufacturing processes.
  • Proven experience managing change control within a GMP environment.

Skills:

• Familiarity with regulatory guidelines (FDA, EMA, ICH Q7/Q8/Q9/Q10).
• Excellent technical writing and documentation skills.
• Strong analytical and problem-solving abilities.
• Ability to work cross-functionally and manage multiple projects simultaneously.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.