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The Zone Operations Manager oversees the manufacturing team to ensure quality and timely production of pharmaceutical products. They manage technician allocation, ensure compliance with cGMP standards, troubleshoot operational issues, and coordinate with other departments. The role requires effective leadership, performance evaluation, and training execution.

The Senior Project Engineer will manage engineering projects in a regulated FDA environment, overseeing project scheduling, documentation, and communication between departments. Responsibilities include preparing project reports, managing invoices, coordinating timelines, and ensuring project scopes are adhered to. The role involves collaboration with engineering SMEs and stakeholders to meet business goals while maintaining project governance standards.

The Sr. Specialist, QA OTF is responsible for providing quality assurance support for GMP manufacturing operations, ensuring compliance with regulatory standards and quality improvements. Primary duties include on-floor oversight, documentation review, AQL inspection, audits, and guiding personnel in cGMP operations.

The Manager, QA OTF is responsible for overseeing the quality assurance program on the manufacturing floor, ensuring compliance with cGMP standards, providing real-time batch record review, and leading a team. The role involves managing daily operations, ensuring the team is trained, handling investigations, and achieving KPIs while fostering a quality-driven culture.

The Senior Scientist, QC supports the environmental testing team by performing microbial controls and ensuring the manufacturing facility is free from microorganisms. Responsibilities include executing cGMP testing, operating lab equipment, authoring technical documents, and entering data into systems. This role requires strong microbiology knowledge and regulatory experience.

The Senior QC Scientist - Compliance role at Catalent involves supporting compliance in the Quality Control Laboratory, handling investigations, deviations, CAPAs, change controls, and quality metrics reporting. The candidate must have 4+ years of experience in a biologic or biopharmaceutical Quality Control Laboratory, with a Bachelor’s degree in a science or engineering field preferred.

The Senior Process Scientist role involves supporting technical transfer and process development for commercial products, acting as a subject matter expert in manufacturing investigations, and leading small projects. Responsibilities include planning development batches, performing analyses, authoring batch records, and ensuring CAPAs are effective.