Process Engineer

Highly Competitive Salary
  1. Permanent
  2. Manufacturing, Design, Operations Management
  3. United States
Burlington, USA
Posting date: 28 May 2021

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.