Principal Process Engineer - Aseptic Fill & Finish
$250,000–$275,000 year
On-site · Boxborough, Massachusetts, United States
Job Summary
As a Principal Process Engineer, you will lead front-end design programming for formulation, sterilization, aseptic processing/filling, and optimized process flow for aseptic processes. You will be responsible for developing early stakeholder alignment with clients and deliver high-quality solutions by evaluating processes, performing risk assessments, and managing regulatory impacts. This role includes participating in business development activities, authoring technical publications, and presenting at industry conferences. A strong background in cGMP and regulatory compliance, along with expertise in sterilization processes and equipment, is required.
Required Qualifications
- Minimum of 20 years of pharmaceutical and biologics process system engineering/design experience
- Expertise in sterilization, aseptic filling (cartridges, vials, syringes), sealing, and handling sterile drug products
- Experience with FDA and EMA regulatory standards
- Excellent communication skills, written and oral, interpersonal skills
Desired Qualifications
- Experience in proposal generation and supporting business development
- Front-end/feasibility study experience
- Working knowledge of process definition means and methods
- Familiarity with 3D modeling, computer-based hydraulic analysis and process simulation software
Additional Requirements
- People from all backgrounds are encouraged to apply
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