Equipment Validation Engineer

Job Title:

GMP Equipment Validation Engineer – CQV

Indianapolis, IN

We are seeking a highly motivated and detail‑oriented GMP Equipment Validation Engineer to support Commissioning, Qualification, and Validation (CQV) activities for a range of manufacturing and utility equipment at a client site. This role is ideal for someone who thrives in a dynamic environment, can work independently, and is confident interfacing directly with client teams.

• Lead and execute CQV activities for GMP equipment including:
  • Autoclaves
  • CIP/SIP systems
  • Bioreactors
  • Incubators
  • Freezers
  • Refrigerators
  • Centrifuges
  • Washers
  • Controlled temperature units
  • Environmental chambers
  • HVAC systems
  • Clean steam generators
  • WFI systems
  • Process tanks
  • Utility systems (compressed air, nitrogen, etc.)
• Develop and review validation documentation including URS, DQ, IQ, OQ, and PQ protocols and reports.
• Perform risk assessments and impact analyses to support validation strategy.
• Coordinate with client engineering, automation, and quality teams to ensure alignment on project goals and timelines.
• Troubleshoot and resolve equipment and process issues during commissioning and qualification phases.
• Maintain compliance with cGMP, FDA, and other applicable regulatory requirements.
• Provide timely updates and communicate effectively with client stakeholders.

• Bachelor's degree in engineering, Life Sciences, or related field.
• 3+ years of experience in CQV within a GMP‑regulated environment.
• Strong understanding of validation lifecycle and regulatory expectations.
• Experience with automated systems and controls integration is a plus.
• Excellent organizational and communication skills.
• Ability to work independently and manage multiple priorities.

At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership.

• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives
• And more — all designed to support your growth, well‑being, and future.

Candidates must be legally eligible to work in the United States without company sponsorship. We are not interested in working on a corp‑to‑corp basis with other companies at this time.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug‑Free Workplace.