Sterile Production Operator (Aseptic & Manufacturing) - Multiple Positions Available
Core
Operate aseptic filling isolators and manufacturing equipment to produce biopharmaceuticals and oligonucleotides in a GMP cleanroom environment.
Role type
Sterile Production Operator (Aseptic & Manufacturing)
Builds
Biopharmaceuticals and oligonucleotides for global markets
Domain
Biopharmaceutical manufacturing / Aseptic processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, aseptic technique, cleanroom operations, digital manufacturing systems (MES, PCS7), analytical testing (pH, density, osmolarity), equipment setup and maintenance, documentation accuracy
Preferred skills
sterile area licence, isolator experience, sterile filling operations support, previous sterile manufacturing experience
Technologies
MES, PCS7, autoclaves, isolators, ISS, RTP/IDC ports
Responsibilities
Qualify and maintain sterile operating licences, perform glove integrity testing and VHP cycles, conduct sterile interventions and environmental monitoring, operate sterile interfaces, prepare equipment via parts washing and autoclaving, complete accurate documentation, participate in troubleshooting and continuous improvement
Seniority
Entry to Mid-level, hands-on IC