Process Engineer II
Process Engineer II in Burlington, MA
AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Process Engineer II will be responsible for facilitating the tech transfer of client processes and executing engineering functions including design and document controls. This individual will also be expected to contribute toward continuous improvement initiatives in support of overall operational efficiencies and improved compliance.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
- 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 client interaction, summarizing engineering-related work completed verbally as well as written.
- Identify and specify process specific equipment needed for client tech transfer, developing techniques and process parameters specific to the clients’ 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.
- Understands and follows OSHA, HAZOP, and AMRI procedures and guidelines when handling or disposing of hazardous materials and maintaining overall safety culture.
- Performs hazardous waste handling operations in accordance with AMRI procedures.
- Bachelors of Science degree in Scientific, Engineering, or related field required
- 3+ years’ experience in a cGMP/FDA regulated environment is preferred Advanced degree in related field may be considered in lieu of experience
- 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
- Computer literate with good working knowledge of spreadsheet software (Visio or equivalent drawing programs a plus)
- 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)
- Aseptic technique, familiarity with clean room personnel flows is desirable
- Experience with CIP/SIP a plus
- Experienced in practicing Quality Risk Management per ICH Q9
All interested applicants must apply online.
AMRI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.