Senior Manufacturing Engineer
Katalyst HealthCares & Life Sciences
Senior Manufacturing Engineer
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.
- Assess 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.
Vacancy posted 12 hours ago
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Katalyst HealthCares & Life Sciences
Raritan, NJ1 day ago
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