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Senior Specialist, Engineering- Biologics External ManufacturingTechnicalOperations
Job in
West Point, Montgomery County, Pennsylvania, 19486, USA
Listed on 2026-10-18
Listing for:
Merck
Full Time
position Listed on 2026-10-18
Job specializations:
-
Pharmaceutical
Validation Engineer, Pharmaceutical Manufacturing, Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
Merck's Large Molecule Technical Operations Unit seeks a Senior Specialist in Engineering to support drug substance technology transfer and commercial manufacturing with external partners in the biologics network. The role involves technical leadership, GMP documentation, process improvement, and on‑site partner coordination.
Responsibilities- Lead technical interface between internal operations and external partner drug substance manufacturers on complex issues
- Author and review GMP documentation including Master Batch Records, change controls, protocols, and regulatory filings
- Manage technical activities for commercial manufacturing including change control, process improvement, and deviation investigation
- Provide on‑site support at external partners for commercial and technology transfer activities
- Ensure external partners maintain inspection readiness and develop standardized work for GMP compliance
- Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry, Biology, or related field
- Minimum 8 years post-degree experience in GMP functional areas or support roles
- Strong analytical problem-solving, root cause analysis, and risk assessment capabilities
- Excellent interpersonal and professional communication skills
- Proven ability to work independently with strong organizational skills and multi-tasking abilities
- Experience in biologics or large molecule manufacturing (preferred)
- Knowledge of regulatory requirements and inspection support experience (preferred)
$117,000-$184,200 base
Position Requirements
10+ Years
work experience
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