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Senior Process Design Engineer (cGMP - Pharmaceutical)

AM Technical Solutions, Inc

AM Technical Solutions, Inc

Design
Posted on Tuesday, February 7, 2023

USA (will allow for REMOTE support with occasional site visits)

Summary:

We are looking for a knowledgeable Process Engineering resource to join our Life Sciences team in support of a pharmaceutical client here in the United States. The ideal candidate should have previous design experience supporting the pharmaceutical or biotech industries. This individual will be responsible for providing technical knowledge and performing Process design work in support of a major capital project. This individual must be able to work on design and perform 3D layouts of complex scopes and equipment.

Roles and Responsibilities:

    • Provide technical knowledge and perform Process design work in support of a major capital project.
    • Work on design and perform 3D layouts of complex scopes and equipment.
    • Develop and review specifications, including design criteria, and participate in activities associated with equipment and material procurement, permitting, and subcontracting.
    • Demonstrated understanding around the following life science equipment: bioreactors, chromatography skids, modular/skidded systems, autoclaves, fermenters, centrifuges, CIP systems, tanks, pumps, heat exchangers, etc.
    • Perform and check calculations, specify equipment, and solve problems of moderate or complex engineering problems.
    • Review vendor equipment documentation within the discipline and from other disciplines for compliance with project requirements, and actively seek discrepancy resolution.
    • Establish, track material key quantities and report costs to project.
    • Review Supplier designs including 3D models, supplier drawings, and documentation.
    • Interface and coordinate with multiple disciplines to integrate equipment design into project.
    • Participate in Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) as needed.

Position Requirements and Qualifications:

  • Minimum 5+ years of relevant work experience in a pharmaceutical or biotechnology environment.
  • PE license and/or other professional certification preferred.
  • Must have demonstrated knowledge and experience with process design within a highly regulated cGMP environment.
  • Requires familiarity with Revit and AutoCAD and similar 3D design software.
  • Knowledge of industry codes such as ASME, ANSI, ASTM, AWS, OSHA, CFR, PIP, etc.
  • Knowledge of validation requirements such as CFR, URS, SRS, TOPs, IQ, OQ, PQ, FAT/SATs, etc.
  • Ability to communicate effectively with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and visitors.
  • Excellent written and verbal communication skills.

Education:

Bachelor’s degree in Chemical Engineering or related discipline.