Project Engineer (cGMP – Pharmaceutical)

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.