Process Engineer – Employers Pro Advantage – Newark, NJ

Employers Pro Advantage Inc. a Native Alaskan Women owned sdb specializing in the placement of highly skilled professionals in Accounting and Finance, IT/MIS and Biomedical. Employers Pro Advantage Inc. has been in business since 1997 servicing New Mexico and the surrounding states with high results.

We are currently looking for a Process Engineer for a contract research and manufacturing pharmaceutical and biotechnology company. This position is located in Albuquerque, NM . Relocation assistance is available.

Essential Duties and Responsibilities include the following:

  • Responsible for leading the tech transfer of client processes and executing engineering functions including design and document controls.
  • Identify and specify process specific equipment needed for client tech transfer.
  • 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.
  • Ability to troubleshoot, amend and accommodate the process of aseptic formulation and fill of drug product such that it harmonizes with HCM Manufacturing Facility while protecting the integrity of client technology/product.

Develop batch records and write reports.

  • Perform aseptic processing operations including equipment preparation and sterilization, aseptic assembly, bulk substance formulation and sterile filtration, to support manufacturing.
  • Execute Engineering functions for all quality system elements, including CAPA’s, DR’s, Change Controls, Design Controls and Document Controls.

Specify and procure new process specific equipment.

  • Work with vendors to manufacture new process equipment as necessary.

Maintain contact and good working relationships with clients.

Job Requirements:

  • Educational Qualification – B.E. Chemical.
  • Experience – 5 to 7 years in pharmaceutical industry.
  • Meticulous and highly organized.
  • Excellent communication skills.
  • Desired – Aseptic technique, familiarity with clean room personnel flows.
  • Desired – Knowledge of process flows – ie. Bio disposables strategies, filtration, mixing strategies, fluid transfer to and from various vessels/bio bags.
  • Desired – Working knowledge of process engineering processing aids such as sanitary connections, valves and pharmaceutical process design.
  • Experience with SIP a plus.
  • Computer literate with good working knowledge of spreadsheet software (Visio or equivalent drawing program a plus).
  • Ability to work with minimal supervision and interact well with clientele as well as inter departmentally.

Employers Pro Advantage, Inc. is an equal opportunity employment agency. We do not discriminate based on race, color, national origin, religion, ancestry, sex, age, disability, serious medical condition, spousal affiliation, sexual orientation, gender identity, or other classifications protected under the law.

Job Type: Full-time

Click Here To Apply

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