Katalyst CRO
Overview
Senior Manufacturing Engineer 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 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 molding a plus.
Engineering degree, preferably ME.
At least 5 years' experience working with automated filling and packaging equipment.
Other details
Seniority level: Associate
Employment type: Contract
Industries: Pharmaceutical Manufacturing
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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 molding a plus.
Engineering degree, preferably ME.
At least 5 years' experience working with automated filling and packaging equipment.
Other details
Seniority level: Associate
Employment type: Contract
Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr