Sr. Specialist, Engineering (Onsite)
Core
Senior technical specialist for commissioning and qualification of an Optima multi-use sterile drug filling line in a cGMP clinical supply facility.
Role type
Senior Specialist, Technical Operations – Engineering (Physical/Clinical Work)
Builds
Clinical supply manufacturing capacity for sterile small molecules, biologics, vaccines, and antibody-drug conjugates.
Domain
Biopharmaceuticals / Sterile Manufacturing / cGMP
Deliverable
physical/clinical work
Required skills
Aseptic processing, Equipment qualification, Troubleshooting, GMP compliance, Mechatronics, Process design, Deviation management, SOP preparation
Preferred skills
Automated aseptic filling lines, Computer-integrated manufacturing (CIM), Robotics operation, Quality systems, New facility startup, Validation support
Technologies
Optima multi-use filler, Lyophilization equipment, Grade A barrier isolation systems, Automated filling lines, Robotics
Responsibilities
Commission and qualify the Optima multi-use filler line, Perform aseptic manipulations within Grade A barrier systems, Provide training on troubleshooting to operators and engineers, Identify and address compliance and process deviations, Maintain contemporaneous records and GXP documentation, Collaborate with scientists, engineers, and vendors on facility design and startup.
Seniority
Senior, hands-on IC