About this role
Job Description
Role Summary
The Chemical Engineering Research & Development department is seeking an engineering associate specialist for the Equipment Development Facilities Engineering team to primarily act as a maintenance team member supporting the API Development facilities, including but not limited to the 800 Prep Lab, as well as potent development labs in Bldg. 800, 818, and 80R. These are potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing facilities located in Rahway, New Jersey. Responsibilities include day-to-day support of lab facility and equipment therein, including reliability, operability/maintainability, and execution of capital and expense projects to enhance facility compliance, new processing technologies, and production capacity.
Key Functions:
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Maintain lab and utility equipment by developing and executing maintenance strategies,
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Perform day-to-day technical oversight of both internal and 3rd party maintenance teams,
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Work with lab process teams to support planning, scheduling and execution of routine corrective/preventive maintenance and facility annual shutdown activities,
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Demonstrate a strong Compliance mindset through application of learned knowledge of cGMP and Safety requirements,
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Support asset compliance, status and disposition via use of computerized maintenance software,
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Interact with Quality groups to support audits, qualify equipment and maintain readiness to perform GMP work,
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Build expertise to ensure effective, safe, and compliant equipment/process setups with line of Sight to the Pilot Plants,
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Leverage learned knowledge to support equipment troubleshooting efforts,
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As part of a team, execute equipment reliability initiatives, facility improvement projects, and new technology implementation in support of development pipeline programs (typ. range of $10K to