Proclinical is currently recruiting for a Process Engineer with a pharmaceutical company located in Burlington, MA.
- Develop batch records for client-specific formulation and filling / finish operations
- Perform processing operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling support to facilitate process design and internal technology transfer
- Operate as an SME for GMP investigations (e.g. CAPA, departures, CCRs) as well as finalize closure reports for departures which are assigned to Process Engineering
- Direct verbal and written client interaction, summarizing engineering-related work completed
- Identify and specify process specific equipment needed for client tech transfer, developing techniques and process parameters specific to the client's product while maintaining critical product attributes
- Author instructions for the operation of equipment and for detailing process flows in clean room facility
- Develop new manufacturing and aseptic filling processes to meet client requirements
Skills and Requirements:
- Bachelor's of Science degree in Scientific, Engineering, or related field required
- 5+ years' experience in a cGMP/FDA regulated environment
- Advanced degree in related field may be considered in lieu of experience
- Aseptic technique, familiarity with clean room personnel/equipment flows is desirable
- Knowledge of process flows - e.g. Disposables strategies, filtration, mixing strategies, fluid transfer to and from various vessels/biobags
- Working knowledge of process engineering processing aids such as sanitary connections, valves and pharmaceutical process design
- Experience with particle size reduction techniques, such as extrusion, microfluidization, or homogenization
- Experience with lyophilization principles
- Familiarity and understanding of cGMP's in a accordance with 21CFR210, and 21CFR211
- Knowledge and understanding of the principles associated with aseptic filling technology (e.g. rotary piston/positive displacement pump, peristaltic pump systems)
- Experienced in practicing Quality Risk Management per ICH
If you are having difficulty in applying or if you have any questions, please contact Jarred Fetterman at 215-531-5593.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.