Senior Process Engineer
Hybrid · Blue Bell, Pennsylvania, United States
Job Summary
Senior Process Engineer to lead the process discipline on high-visibility life sciences projects (biotech, oral solid dosage, aseptic processing). Responsible for client-facing engagement, front-end project definition, and design of cGMP facilities; develop deliverables such as Process Flow Diagrams, Mass Balances, P&IDs, Equipment Specifications, and Process Simulation; collaborate with architecture, process utilities, and mechanical/electrical/plumbing disciplines; provide guidance on process requirements, through analyses like PHAs and regulatory risk assessments; lead or participate in projects, support business development, and mentor junior engineers. Must possess strong communication skills, be capable of leading independent projects or small teams, and stay current with FDA/EU regulations and ISPE/BPE guidance. Travel to client sites is expected; hybrid work schedule offered. Minimum qualifications include a BS in Chemical or Mechanical Engineering and 10+ years in cGMP life sciences; preferred qualifications include SCADA experience, ISPE/PDA involvement, and PE licensure.
Required Qualifications
- BS in Chemical Engineering or Mechanical Engineering
- 10+ years of experience in design and development of cGMP operations and equipment in Life Sciences
- Experience with design and/or operation of cGMP manufacturing systems
- Ability to communicate process concepts to clients and peers
- Office software proficiency (MS Office)
- Strong written and oral communication skills
- Ability to work under pressure and manage multiple projects
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