MES Validation Engineer - Southern California

About the role

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.

Key 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
• Coverage of 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

Preferred Qualifications

• 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

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.

Compensation

Salary Range: $75 - $85 / hour. This range is an estimate of pay for project-based employment and varies based on experience, technical skillset, and project scope.

Benefits

• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives

Contact Information

If you are an experienced MES Validation Engineer with strong CSV experience and are interested in supporting cutting-edge manufacturing in the life sciences industry, we encourage you to apply!