Validation Engineer
About the Role
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. 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
- 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.
About Valspec
Valspec is a specialized Commissioning, Qualification, Validation, Automation, and Digital GxP consulting organization supporting leading pharmaceutical and biotechnology companies across North America. Since 1999, Valspec has delivered high-quality engineering and compliance solutions that help bring lifesaving therapies to market. Valspec is an ESOP company focused on technical excellence, integrity, and employee ownership.
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.