Katalyst CRO
Overview
Join to apply for the
Senior Manufacturing Engineer
role at
Katalyst CRO . 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 systems. 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. Job Details
Location: Plainsboro, NJ We are removing boilerplate and extraneous job board noise to present a concise description focused on the role, responsibilities, and required qualifications.
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Join to apply for the
Senior Manufacturing Engineer
role at
Katalyst CRO . 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 systems. 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. Job Details
Location: Plainsboro, NJ We are removing boilerplate and extraneous job board noise to present a concise description focused on the role, responsibilities, and required qualifications.
#J-18808-Ljbffr