Process Engineer job in Burlington, USA

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Job type: Permanent

Discipline: Manufacturing, Design, Operations Management

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Process Engineer with a pharmaceutical company located in Burlington, MA.

Job Responsibilities:

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.

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