MES Validation Engineer - Southern California
External
Valspec · Non-headquartersPrepare for this interview
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Responsibilities
- Generate and execute IQ, OQ, and PQ protocols for Werum PAS-X MES following a risk-based validation approach
- Support validation strategy development aligned with FDA regulations, GMP guidelines, and 21 CFR Part 11
- Define and author validation deliverables, including validation plans, protocols, and reports
- Coordinate validation activities with internal teams and external vendors to meet project timelines
- Perform risk assessments and impact analyses to identify critical MES system functions
- Execute validation protocols and document results, including deviations, exceptions, and corrective actions
- Generate validation summary reports, traceability matrices, and final qualification documentation
- Review vendor documentation including URS, functional specifications, and design documents
- Support updates to controlled documentation including SOPs, forms, and validation records
- Required Qualifications
- Bachelor's degree in Engineering, Computer Science, or a related technical field
- 5+ years of MES CSV validation experience in a regulated life sciences or biotechnology environment
- Hands-on experience executing IQ, OQ, and PQ protocols
- Strong knowledge of FDA regulations, GMP, and 21 CFR Part 11
- Experience with validation documentation including protocols, reports, and traceability matrices
- Strong analytical and problem-solving skills
- Excellent communication and collaboration skills
Requirements
- Experience with Werum PAS-X (Master Batch Records, Electronic Batch Records, Review by Exception)
- Prior MES validation experience in cell and gene therapy or biologics manufacturing
- Understanding of MES system integration and data flow
- Experience reviewing vendor deliverables and system documentation
- Strong GMP technical writing skills
- What Makes a Strong Fit for This Engagement
- Because this is an active validation engagement, the ideal candidate can contribute with minimal ramp-up and has recent hands-on MES validation experience. Candidates with Werum PAS-X experience and prior consulting or contract experience in regulated environments will stand out.
Benefits
Additional Information
Valspec-a global provider of system validation and lifecycle services-provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies. MES Validation Engineer (Consultant) - Contract Engagement: Valspec consultant placed onsite at a leading life sciences manufacturing site in Southern California Location: West Covina, CA (onsite) Type: Contract / consulting - initial term approximately 6-7 months, with a strong likelihood of extension Start: ASAP About the Engagement Valspec is seeking an experienced MES Validation Engineer to support Werum PAS-X Manufacturing Execution System (MES) validation activities at a leading life sciences company focused on cell and gene therapy. This is a consulting engagement supporting an active validation effort, requiring a candidate who can quickly contribute to validation deliverables in a GMP-regulated environment. Role Overview The MES Validation Engineer will support computerized system validation activities for Werum PAS-X MES, including the generation and execution of validation deliverables following a risk-based approach. This role partners closely with cross-functional teams to ensure systems meet regulatory requirements and industry standards. The position focuses on validation planning, execution, and documentation across the system lifecycle, with an emphasis on compliance, accuracy, and on-time delivery.
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