Process Engineer; Fill-Finish

Main Responsibilities (SME – fill-finish related projects)

• Assist and develop technically sound process equipment concepts and scope
• Specify and design process equipment
• Manage equipment vendors to meet requirements, cost, and schedule
• Develop and execute commissioning and qualification (CQ) documentation
• Involve Maintenance, Operations, Engineering, Quality, and Continuous Improvement during design
• Ensure knowledge transfer at project close for appropriate support of process equipment

• Train and support development
• Interface with Operations to ensure equipment meets production requirements
• Provide input to quality and safety systems
• Provide advanced technical support to diagnose and resolve complex system issues, minimizing downtime
• Identify and implement improvements to enhance efficiency, safety, and quality

• Compliance (deviations, CAPA, change control, training)
• Work order metrics; CQ completion rate
• Deviations and discards due to equipment issues

• BS in Engineering (Chemical or Mechanical preferred) or related field
• 5+ years in aseptic processing, sterile manufacturing, or fill‑finish engineering; hands‑on experience with filling equipment and aseptic barriers

• Technical knowledge of drug product processes; automated mechanical systems
• GMP knowledge for manufacturing and CQ activities; analytical and troubleshooting skills
• Experience with lyophilization, CIP/SIP systems, filling technologies; sterile manufacturing
• Ability to lead small projects; understanding of utilities impact
• Cost / schedule / scope management; automation design / testing knowledge; proficient in written / spoken English

Healthcare / wellbeing programs and at least 14 weeks’ gender‑neutral parental leave.