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Production Manager

Lupin · Pune/Pimpri Chinchwad et périphérie

Senior 🇬🇧 English
SAP CIP SIP Equipment qualification

Job description

About the role

We are seeking a Production Manager to lead the preparation and execution of manufacturing batches in a biosimilar production environment. The role ensures equipment readiness, raw material availability, and smooth shop‑floor operations throughout campaigns.

Key responsibilities

  • Ensure equipment and instruments are ready for each process.
  • Verify availability of raw materials, accessories and consumables before batch execution.
  • Prepare, review and update process, equipment and area SOPs and EOPs.
  • Develop and execute qualification and validation protocols for processes, equipment and areas.
  • Generate reports on process, equipment, area qualification and validation.
  • Prepare, review and issue Batch Production Records (BPR) and study protocols.
  • Maintain readiness of downstream, corridor and washing areas for manufacturing.
  • Support smooth shop‑floor functions during manufacturing campaigns.
  • Raise and review change controls and deviations as required.
  • Handle SAP activities related to process and maintenance.
  • Operate downstream equipment for process runs and CIP/SIP operations.

Required profile

  • 11 to 16 years of experience in biosimilar manufacturing or related production environments.
  • Post‑graduation (M.Sc. or B.Tech) in Biotechnology, Biochemistry or a related field.
  • Experience with production planning and quality management systems (QMS).

Required skills

  • SAP for process and maintenance management.
  • CIP (Clean‑In‑Place) and SIP (Sterilization‑In‑Place) procedures.
  • Equipment qualification and process validation.
  • Batch Production Record (BPR) preparation and management.
  • Downstream equipment operation.

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Published 3 months ago

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Lupin

Pune/Pimpri Chinchwad et périphérie