Project Engineer (cGMP - Pharmaceutical)

AM Technical Solutions Austin, Texas
engineer cgmp engineering design qualification technical biopharma project engineering engineering support maintenance utility operations vendors
November 17, 2022
AM Technical Solutions
Austin, Texas
FULL_TIME

AM Technical Solutions is looking for a proven Senior Project Engineer to work with a BioPharma client in the Boston, MA area. Ideal candidates should have a strong understanding of GMPs and experience providing Project Engineering support in highly regulated or pharmaceutical/biotech facilities. This individual should also have a strong understanding around process engineering as well.

Roles and Responsibilities:

  • Provide engineering and technical support related to operation, maintenance, design, installation, start-up/commissioning, testing and qualification of product and infrastructure equipment and systems.
  • Systems may include production equipment such as bioreactors, fermenters, centrifuges, UFDF, Chromatography, CIP skids, and other support equipment such WFI, CS, Process Gases, HVAC, and Core Building Utility Systems.
  • Support the design and qualification of improvements, changes or upgrades to the equipment and startup and validation documents.
  • Lead projects of various complexities to support departmental initiatives and participate in various cross-functional teams to support process improvements.
  • Identify and schedule project events around manufacturing operations.
  • Identify materials required to support project execution work.
  • Communicate project requirements to vendors to obtain proposals for equipment and piping changes.
  • Provide project design and cost estimates.
  • Manage project implementation including oversight of selected vendors.
  • Redline drawings to prepare the As-Built set and maintain the site master drawing.

Position Requirements and Qualifications:

  • Minimum 5+ years experience providing Project Engineering support.
  • Candidate must be able to work across functional areas such as operations, maintenance, quality and validation.
  • Proficiency in the arena of process, utility and building engineering in cGMP environment within a biopharma facility.
  • Working knowledge of documents such as P&IDs, URS, FRS, and qualification documents.

Education:

  • Bachelors degree in Mechanical or Chemical Engineering.

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