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Process Engineer

Sterile Pharmaceuticals Manufacturing
Charleston, South Carolina, United States
September 16, 2017

Process Engineer - $90-110K – Sterile Pharmaceuticals Mfg - Provides technical support for the manufacturing facility, including the design, selection and commissioning of process contacting equipment, CIP/SIP and clean utilities. The Process Engineer will be part of a dynamic group of engineers who will be responsible for trouble shooting, determining root cause of problems and providing optimization strategies for process support equipment within multi-product cGMP facilities regulated by multiple entities. This role will be a major contributor during the transfer of new processes and technologies to the Charleston Site. This role serves as subject matter expert for cleaning (CIP/COP), sterilization (SIP, VHP) and single-use systems. Duties will include troubleshooting of validated processes, Equipment, Facility and Utility (EFU) validation support and providing technical assessments for process deviations and investigations. Develop and execute engineering tests, FATs, SATs and commissioning test plans and train operations staff on new/revised operating procedures. Create and improve templates to be for URS/FS/DS. Identifies equipment specific best practices and performs gap analysis between Alcami and industry best practices. Keep abreast of advancement in new technologies. Responsibilities include supporting all respects of the validation process, including developing and performing qualifications studies to document evidence to ensure that equipment and processes will satisfactorily meet the client and facility specifications for quality. Provide peer review for Engineering documentation. Will act as project manager for small process equipment and utility projects. Reporting to the Director of Engineering, Validation, and Maintenance (EVM).

BS Engineering with minimum 8 years’ experience in a sterile manufacturing environment. MS Engineering with minimum 4 years’ experience in a sterile manufacturing environment. Excellent understanding of pharmaceutical manufacturing and packaging of sterile manufacturing products. Excellent understanding of the aseptic principles of technology transfer processes, investigations, scale up, process validation and optimization of sterile product manufacturing spanning the entire product life cycle.

Key Job Responsibilities: Propose and improve design criteria for EFU; Lead and support engineering projects; Draft and execute EFU validation; Create and execute complex validation protocols; Identify and solve problems independently with minimal oversight; Provide technical assistance for process transfer and validation efforts; Compose process validation, cleaning validation and process optimization protocols; Clearly and accurately document activities; Identify specific parameters, sampling and tests used in the validation protocols of new and existing products; Ensure transfer of information from validation activities to batch records and procedures; Monitor manufacturing processes during production to assess any technical process issues; Lead investigations and complete CAPA assignments