As API Process Engineer, you will work as part of a cross-functional matrix team to ensure successful manufacture of active pharmaceutical ingredients, chemical intermediates and specialty materials to support development of R&D pipeline products.
Key responsibilities include:
Key responsibilities include:
- Provides process engineering expertise to technology transfer of projects to internal and external manufacturing locations.
- Perform process engineering analysis to determine cycle time, equipment fit, technologies required, scale up risk, etc.
- Recommend laboratory experiments to inform scale up plans.
- Provide process engineering expertise within process planning workflows and document reviews for internal and external manufacturing implementation including: tech transfer documentation, data/process knowledge collection, equipment setup, process modeling, process flow diagrams, compatibility assessments, risk management, etc.
- Perform engineering analysis of process execution, recommends opportunities for improvement with plant efficiency and risk mitigation as goals, and captures analysis in campaign summary documents
- Provide process engineering expertise to the Hazard Evaluation Lab and the Process Hazard Analysis team to identify requirements for non-standard engineering controls within process implementation.
- Provide on-site support for external implementations and execution at clinical manufacturing suppliers.
- Serves as subject matter expert for Delta-V recipe construction. Maintains standard recipe components within the process automation system.
- Provide process expertise in post-batch record review and analysis in conjunction with building management and external implementation team.
- Support process validation and commercialization activities for late stage process transfers to external suppliers.
- Act as a quality events investigator for assigned projects.
- Must have a B.S. or M.S. with a minimum of 3-5 years relevant industrial experience in process scale-up or process development.
- Operational manufacturing or pilot plant experience of API, chemical intermediate, and/or specialty material.
- Strong technical skills (chemistry, process development, chemical processing equipment), with a proficient understanding of GMP and safety regulations is required.
- Strong knowledge of plant scale unit operations, scale-up, process fit, equipment capabilities, and process implementation.
- Candidates must possess excellent problem solving skills and be able to work effectively with multiple assignments.
- Candidates must have demonstrated the ability to work independently and also as part of multidisciplinary project team.
- Essential to success are the ability to build strong working relationships with internal and external partners, to apply cooperation principles and ways of working in a matrix environment.
- Demonstrated strength in all modes of communication with internal and external partners.
- Up to 10-15% percent domestic and/or international travel annually.