Process Engineer - Lyophilization & Isolator Systems
Stark Pharma Solutions Inc
Position: Process Engineer - Lyophilization & Isolator Systems
Location: West Point, PA
Duration: Long Term
Job Overview
We are seeking an experienced Process Engineer to support the startup and commissioning of a new GMP manufacturing facility. The ideal candidate will provide technical oversight for lyophilization and isolator systems while working closely with Engineering, CQV, and Operations teams to ensure successful equipment installation, startup, commissioning, and GMP readiness.
Key Responsibilities
- Provide technical support for the installation, startup, and commissioning of lyophilizers, isolators, and associated aseptic process equipment.
- Collaborate with CQV teams to support commissioning, qualification, and equipment turnover activities.
- Coordinate with vendors, contractors, and cross-functional teams throughout project execution.
- Support Process Hazard Analyses (PHAs) and ensure equipment is implemented in accordance with GMP and site safety requirements.
- Troubleshoot equipment issues during startup and support operational readiness.
- Ensure compliance with GMP requirements throughout equipment startup and commissioning.
- Assist with engineering documentation and process improvement activities.
Required Qualifications
- Bachelor's degree in Engineering or a related technical discipline.
- Minimum 5 years of engineering experience in pharmaceutical or biotech manufacturing.
- Hands-on experience with lyophilization (freeze dryers), isolator systems, or aseptic processing equipment.
- Experience supporting GMP equipment startup, commissioning, and qualification activities.
- Familiarity with CQV (Commissioning, Qualification & Validation) processes.
- Experience supporting facility startups, equipment installation, and commissioning projects.
- Knowledge of sterile pharmaceutical manufacturing and GMP regulations.
- Experience participating in Process Hazard Analyses (PHAs) is preferred.
- Strong communication, troubleshooting, and cross-functional collaboration skills.
Vacancy posted 1 day ago
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