Senior Manager or Manager, Pharma Manufacturing (liquids)
Bleeding edge nuclear pharma
Job Requisition # 6752
The Sr Manager, or Manager, Manufacturing Engineering is a hands-on manager role responsible for the transfer of new isotopes production processes and systems into manufacturing. Will additionally oversee on-going production support, validation, and process improvement for existing isotope processes. Involves a strong focus on day to day support of production lines to meet quality and production goals. Will build a new team of Manufacturing Engineers to manage. All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards. This position will assist the product and process development teams with creation and implementation of simple to complex manufacturing process designs in compliance with cGMP regulations.
This position will be responsible for defining and creating new procedures for documenting or qualifying equipment/processing which can be transitioned to manufacturing production engineering team members. The successful candidate will be familiar with manufacturing within the
medical device/pharmaceutical industry and possess in-depth engineering knowledge in science.
- Hire and manage engineering team responsible for the transfer of new isotope manufacturing processes/systems to production. Will provide hands-on direct involvement.
- Provide manufacturing engineering and support on Isotopes processing system development projects to ensure new production processing systems are ready for transfer to production
- Responsible for oversight of production documentation including work instructions and batch production records.
- Develop/execute strategy for ongoing support and maintenance of new isotopes production processes and systems.
- Plan and execute ongoing process improvements to meet quality and production goals.
- Involvement with Acceptance Testing of complex custom equipment
- Develop and execute standards and processes for qualification and process validation
- Ensure production equipment is capable and has capacity for growth, involving integrating equipment, people, material flow systems, and information systems.
- Develop and maintain cGMP compliant process work instructions, batch production records, reports, and plan documentation
- Establish system level metrics and test plans by collaborating with engineering and RA/QA teams to ensure the product meets performance requirements involving accuracy, repeatability, and reliability.
- Support investigations including complaint, event, CAPA, deviation and out of specification
- Bachelor’s degree in Engineering
- 7+ years’ experience in Manufacturing Engineering
- Management experience
- Experience working in an FDA and/or GMP regulated environment.
- Experience executing process validation and documentation activities (IQ/OQ/PQ)