Process Engineer (cGMP – Engineering Support)

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: 

Process Engineer (cGMP – Engineering Support)

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 Process Engineer to work with a pharmaceutical client of ours in the Boston, Massachusetts area. Ideal candidates should have a strong understanding of GMPs and experience providing engineering support in highly regulated or pharmaceutical/biotech facilities.

 

Direct Involvement Opportunities:

  • Responsibilities will focus around operational support for a multiproduct GMP manufacturing site.
  • Supporting/troubleshooting equipment.
  • Ownership of small projects and quality systems.
  • Familiarity of Manufacturing Systems Lifecycle approach.
  • Must be familiar with CAPAs, deviations, and change control protocols.

 

Qualifications, Skills, And Experience:

    • BS/MS in Mechanical or Chemical Engineering, or related field/experience.
    • 2+ years’ of experience working within a GMP or highly regulated engineering environment.
    • Ability to work independently on projects with applicable client stakeholders in Validation, Quality Assurance, Manufacturing, Maintenance, and other relevant personnel.
    • Strongly motivated, well-organized, and shows professional initiative.
    • Takes ownership of assignments, can work both independently and as part of the team.
    • Ability to work in a fast-paced and challenging environment.
    • Excellent organization skills with the ability to manage multiple tasks simultaneously.