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Senior Manufacturing Engineer
Senior Manufacturing EngineerKatalyst Healthcares and Life Sciences • Bridgewater, NJ, United States
Senior Manufacturing Engineer

Senior Manufacturing Engineer

Katalyst Healthcares and Life Sciences • Bridgewater, NJ, United States
1 day ago
Job type
  • Full-time
Job description

Job Description :

As Senior Manufacturing Engineer, you'll shape the future of diagnostic production processes. You'll define equipment specifications, lead automation initiatives, and drive projects that cut downtime, boost yield, and ensure cGMP compliance-directly impacting product quality and operational excellence.

Responsibilities :

  • Influence the design, scale-up, and optimization of manufacturing equipment.
  • Lead cross-functional teams to deliver complex projects on time.
  • Champion quality and compliance with cGMP and ISO standards.
  • Work on cutting-edge packaging, micro dispensing, and automation system.
  • Plan and manage filling / packaging projects, ensuring specs align with marketing goals.
  • Create user requirements, bid packages, and validation protocols (IQ / OQ / PQ).
  • Reduce downtime and improve repair efficiency across equipment systems.
  • Develop SOPs, records, and specifications to support manufacturing launches.
  • ssess and implement quality and process improvements.

Requirements :

  • Degree in Mechanical or related engineering field.
  • Experience with cGMP manufacturing and automated filling / packaging systems.
  • Knowledge of IQ / OQ / PQ validation and FDA compliance.
  • Background in material science, micro dispensing, or injection moulding a plus.
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    Senior Manufacturing Engineer • Bridgewater, NJ, United States

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