Project Engineer (cGMP – Pharmaceutical)

AM Technical Solutions- Who Are We:

AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives.  Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers.  AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.

 

Job Title: 

Project Engineer (cGMP – Pharmaceutical)

Current Locations:

AMTS has opportunities throughout the country and overseas supporting multiple locations in MA, NH, RI, NC, Europe, and other locations.

Position Description

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.

 

Direct Involvement Opportunities:

  • 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.

Qualifications, Skills, And Experience:

    • Bachelor’s degree in Mechanical or Chemical Engineering.
    • 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.
    • Effective verbal and written communication skills.

    Excellent interpersonal, teamwork, and leadership skills required.