Equipment Validation Engineer
Job Title: GMP Equipment Validation Engineer – CQV
Location: Oceanside, CA
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.
Our CQV team collaborates closely with the client across multiple facets of controls and automation, ensuring seamless integration and compliance with regulatory standards. The ideal candidate will bring strong technical expertise, excellent communication skills, and a proactive approach to problem-solving. The ideal candidate has experience leading the equipment CQV efforts of a team that also includes computer system validation engineers and specialists.
Key Responsibilities
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.
Qualifications
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.
Benefits
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.
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.
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