Job description

Packing Sterile: Operator

Sterile Packing Machine Operation: Set up, assemble, and operate primary and secondary packaging machinery for injectables (vials, ampoules, pre-filled syringes, BFS/FFS) in compliance with BPR specifications.
Aseptic & Visual Inspection: Perform online visual inspection (or monitor automated inspection systems) for clarity, particulate matter, container integrity, volume levels, and sealing defects.
Line Clearance Execution: Execute thorough area cleaning, equipment sanitation, and line clearance protocols (Type A/B) during product changeovers to prevent cross-contamination or line mix-ups.
Leak & Seal Testing: Conduct routine in-process seal integrity testing (dye ingress, high-voltage leak detection, vacuum decay) and track parameter checks for aluminum cap crimping or ampoule sealing.
Packaging Material Handling: Receive, verify batch details, and load primary/secondary materials (aluminum caps, trays, cartons, leaflets, outer shippers) under controlled packaging environment standards.
Logbook & BPR Entries: Record real-time machine operating data, downtime, rejected quantities, and room conditions in Batch Packing Records (BPR) and equipment logbooks adhering to ALCOA+ rules.
Troubleshooting & Maintenance: Identify minor mechanical or pneumatic machine faults during operations (e.g., optical sensor misalignment, star-wheel jams) and assist maintenance technicians with changeovers.
Material Yield & Reconciliation: Calculate and reconcile used, unused, and rejected packaging components at the end of each shift to ensure accurate batch material balances.
Audit & Cleanroom Compliance: Keep the sterile packing suite, machine surfaces, and documentation organized, clean, and ready for internal and external regulatory inspections (USFDA, EU Annex 1, WHO).
EHS & Cleanroom Hygiene: Adhere to cleanroom zoning guidelines, wear mandatory personal protective equipment (PPE), follow strict personal hygiene standards, and maintain workplace 5S discipline.

Someone shared one job with you. ASAI keeps finding the rest.

Scored, not searched. Every role ranked against your actual profile.

Alerts as often as hourly. Reach new roles while the pile is still small.

Skill gaps, spelled out. See exactly which requirements you don't meet yet.

Verified jobs, only. Say no to ghost jobs. Your time deserves respect.

Someone shared one job with you. ASAI keeps finding the rest.

Scored, not searched. Every role ranked against your actual profile.

Alerts as often as hourly. Reach new roles while the pile is still small.

Skill gaps, spelled out. See exactly which requirements you don't meet yet.

Verified jobs, only. Say no to ghost jobs. Your time deserves respect.

Job description

Packing Sterile: Operator

Sterile Packing Machine Operation: Set up, assemble, and operate primary and secondary packaging machinery for injectables (vials, ampoules, pre-filled syringes, BFS/FFS) in compliance with BPR specifications.
Aseptic & Visual Inspection: Perform online visual inspection (or monitor automated inspection systems) for clarity, particulate matter, container integrity, volume levels, and sealing defects.
Line Clearance Execution: Execute thorough area cleaning, equipment sanitation, and line clearance protocols (Type A/B) during product changeovers to prevent cross-contamination or line mix-ups.
Leak & Seal Testing: Conduct routine in-process seal integrity testing (dye ingress, high-voltage leak detection, vacuum decay) and track parameter checks for aluminum cap crimping or ampoule sealing.
Packaging Material Handling: Receive, verify batch details, and load primary/secondary materials (aluminum caps, trays, cartons, leaflets, outer shippers) under controlled packaging environment standards.
Logbook & BPR Entries: Record real-time machine operating data, downtime, rejected quantities, and room conditions in Batch Packing Records (BPR) and equipment logbooks adhering to ALCOA+ rules.
Troubleshooting & Maintenance: Identify minor mechanical or pneumatic machine faults during operations (e.g., optical sensor misalignment, star-wheel jams) and assist maintenance technicians with changeovers.
Material Yield & Reconciliation: Calculate and reconcile used, unused, and rejected packaging components at the end of each shift to ensure accurate batch material balances.
Audit & Cleanroom Compliance: Keep the sterile packing suite, machine surfaces, and documentation organized, clean, and ready for internal and external regulatory inspections (USFDA, EU Annex 1, WHO).
EHS & Cleanroom Hygiene: Adhere to cleanroom zoning guidelines, wear mandatory personal protective equipment (PPE), follow strict personal hygiene standards, and maintain workplace 5S discipline.