Process Engineering Supervisor

7 days ago

Bengaluru, Karnataka, India Biocon Biologics Limited Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Department: Process Engineering

Key Responsibilities:

  • Lead technology transfer from bench/pilot scale to commercial manufacturing.
  • Manage scale-up activities and ensure facility/process compatibility.
  • Drive equipment and facility fitment assessments during project implementation and routine manufacturing.
  • Lead and coordinate qualification and validation activities (IQ, OQ, PQ) in compliance with regulatory requirements.
  • Troubleshoot and resolve process and equipment-related deviations, providing robust engineering solutions.
  • Manage and support change control, CAPA, and investigation processes.
  • Collaborate with cross-functional teams (Manufacturing, Quality, R&D, Engineering) to ensure successful execution of projects.
  • Ensure timely documentation and closure of GMP documents related to engineering and validation.
  • Utilize TrackWise for quality and compliance documentation, SAP for inventory and equipment management, and MS Project for planning and tracking.

Required Qualifications:

  • Bachelors degree in Chemical Engineering or Biotechnology.
  • Minimum 10 years of relevant experience in biotech/pharmaceutical manufacturing, specifically in process engineering and project management.
  • Strong understanding of downstream & Upstream processing operations (Chromatography, Ultrafiltration, Nanofiltration, etc.).
  • Demonstrated experience in executing validation lifecycle documents including IQ, OQ, PQ.
  • Proficient in using TrackWise, SAP, and MS Project.
  • In-depth knowledge of GMP, regulatory compliance, and tech transfer practices.

Preferred Skills:

  • Strong analytical and problem-solving skills.
  • Excellent communication and cross-functional collaboration abilities.
  • Experience working with regulatory audits and documentation.
  • Ability to work independently and manage multiple projects simultaneously.

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