Validation Engineer

Validation Engineer (CQV)

Valspec is seeking a hands-on Validation Engineer (CQV) to support commissioning, qualification, and validation activities at a cutting-edge pharmaceutical manufacturing facility in El Segundo, California.

If you enjoy being in the field, working directly with equipment, utilities, facilities, and cleanroom systems, this is an outstanding opportunity to join a team of experienced validation professionals supporting critical GMP manufacturing operations.

This role is ideal for engineers who thrive in fast-paced project environments and have practical experience with Facilities, HVAC, Cleanrooms, and Utility Systems within pharmaceutical, biotechnology, or aseptic manufacturing operations.

Key Responsibilities

• Execute commissioning, qualification, and validation activities for GMP facilities and manufacturing systems.
• Develop and execute IQ, OQ, and PQ protocols.
• Generate validation protocols, summary reports, deviations, and protocol exceptions.
• Support qualification of facility systems, cleanrooms, HVAC systems, and GMP utilities.
• Schedule, coordinate, and execute qualification activities with cross-functional project teams.
• Review commissioning documentation and ensure readiness for qualification testing.
• Participate in project meetings as the CQV representative.
• Maintain GMP-compliant validation documentation.
• Support startup, troubleshooting, and system turnover activities.
• Work directly in manufacturing and facility environments with significant field presence.

Required Experience

Must Have

• 2-4 years of validation experience in pharmaceutical, biotechnology, cell therapy, gene therapy, or similar regulated manufacturing environments.
• Equipment Validation (CQV) experience within a life sciences manufacturing environment.
• Direct experience authoring and executing validation protocols.
• Experience generating IQ/OQ/PQ documentation, validation summary reports, and protocol exceptions.
• Strong understanding of cGMP documentation requirements.
• Experience scheduling and executing qualification activities.

Strongly Preferred

• Facility Qualification experience.
• HVAC Qualification experience.
• Cleanroom Qualification experience.
• Utility Qualification experience including systems such as:
• WFI
• Purified Water
• Clean Steam
• Compressed Air
• Process Gases
• Experience supporting aseptic manufacturing, fill-finish, biotech, or sterile processing environments.
• Familiarity with ASTM E2500 and modern CQV methodologies.
• Ability to work independently in a highly collaborative project environment.

What We're Looking For

Hands-on, field-oriented engineer Comfortable working onsite daily Strong technical writing skills Ability to interface with Operations, Engineering, Quality, and Validation teams Self-starter who enjoys solving problems and driving project execution

Compensation

Salary Range: $90,000 - $110,000 annually

Salary range is an estimate for project-based employment and varies based on experience, qualifications, and employment type. Higher compensation may be available for highly qualified consultants, independent contractors, or short-term project assignments.

Ready to Make an Impact?

Join Valspec and help support the facilities and manufacturing systems that deliver critical therapies to patients around the world.

When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored.

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

Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

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.