Logo
Katalyst Healthcares and Life Sciences

Katalyst Healthcares and Life Sciences is hiring: Manufacturing Engineer in Flor

Katalyst Healthcares and Life Sciences, Florham Park, NJ, US, 07932

Save Job

Responsibilities:
Senior Manufacturing Engineer Location:
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 molding a plus.
  • Must have an Engineering degree preferably ME.
  • t least 5 years' experience working with Automated Filling and packaging equipment.