Sr. Engineer, MS&T – Aseptic Drug Product
Core
Lead aseptic manufacturing operations, process performance, and technical investigations for sterile drug products.
Role type
Senior Manufacturing Science and Technology Engineer (Aseptic Drug Product)
Builds
Reliable supply of high-quality sterile medicines
Domain
Biopharmaceutical manufacturing / Aseptic fill-finish
Deliverable
physical/clinical work
Required skills
GMP compliance, aseptic fill-finish operations, process validation, tech transfer, root cause analysis, process data analysis, continuous improvement, process change documentation, OPEX initiatives
Preferred skills
Applied statistics, data analytics, risk management, technical leadership
Technologies
Manufacturing processes, manufacturing technologies
Responsibilities
Lead CPV activities by analyzing process data and driving performance improvements; Serve as technical lead for manufacturing investigations and root cause analysis; Partner with Manufacturing to support production schedules and GMP compliance; Monitor and trend CQAs and CPPs; Identify and implement process improvements; Support introduction of new equipment and processes; Author process change documentation; Provide technical expertise for remediation and project deliverables; Collaborate on Tech Transfer activities; Drive OPEX initiatives
Seniority
Senior, hands-on IC