Process Engineer
$177,840–$177,840 year
On-siteSwiftwater, Pennsylvania, United States
Job Summary
Design process equipment concepts and specify technical solutions for drug substance projects while managing vendor requirements to meet cost, schedule, and scope targets. Lead commissioning, qualification, and start-up activities, actively collaborating with Maintenance, Operations, Quality, and Continuous Improvement teams throughout the design process. Diagnose complex system issues to minimize downtime, implement process improvements for efficiency and safety, and ensure knowledge transfer at project conclusion. Manage engineering deliverables with strict deadlines while maintaining compliance with GMP and regulatory standards. Support root cause investigations for deviations and provide advanced technical troubleshooting for production equipment.
Required Qualifications
- Bachelor of Science in Engineering (Chemical preferred; other engineering disciplines accepted)
- 4+ years process engineering experience relevant to life sciences and/or vaccine manufacturing
- Technical knowledge of drug substance processes with a focus on process equipment
- Understanding of automated mechanical systems
- Understanding of instrumentation
- Strong analytical skills (ability to apply engineering principles to design)
- Hands-on troubleshooting skills
- Knowledge of pharmaceutical processes
- Knowledge of GMP (Good Manufacturing Processes) regulatory requirements for pharmaceutical industry manufacturing and CQ activities
- Sound organizational, written, and oral communication skills
- Proficiency in both written and spoken English
Desired Qualifications
- Ability to lead small projects as a project manager
- Ability to be an equipment system lead
- Understanding of the impact of utilities on equipment design and operation
- Understanding of cost, schedule, and scope management
- Knowledgeable of automation design and testing processes
- Equipment FAT, SAT, and start up experience
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