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Immacule Life Sciences

Executive - Process Engineering (Injectable)

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Job Description

Job Responsibilities

  • Handling and troubleshooting of sterile manufacturing and filling equipment.
  • Managing equipment breakdown activities, root cause analysis, and CAPA implementation.
  • Preparation, review, and execution of equipment qualification documents and technical documentation.
  • Monitoring preventive maintenance activities to ensure minimum equipment downtime.
  • Execution and monitoring of production and engineering activities in compliance with cGMP requirements.
  • Preparation and review of SOPs, protocols, reports, and other GMP documentation.
  • Ensuring adherence to aseptic practices and cleanroom behavior standards.
  • Independently handling and managing shopfloor activities effectively.

Eligibility Criteria

  • Minimum 6 years of relevant experience in sterile pharmaceutical manufacturing facilities.
  • Candidates from sterile injectable pharmaceutical facilities will be preferred.
  • Immediate joiners or candidates serving short notice periods will be preferred.

Mandatory Equipment Exposure

Candidates must have hands-on experience with sterile injectable manufacturing equipment including:

  • Filling Lines: B+S, Bosch, Groninger, IMA, Tofflon, Optima, Truking, Steriline, etc.
  • Lyophilizers
  • Autoclaves
  • Manufacturing & Holding Vessels

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Job ID: 148889833