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
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:
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.
- 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.