Senior Process Engineer (cGMP – Pharmaceutical Downstream)

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: 

Senior Process Engineer (cGMP – Pharmaceutical Downstream)

Current Locations:

AMTS has opportunities throughout the country and overseas supporting multiple locations. This particular need is in the Greater Boston Area (MA).

Position Description

AM Technical Solutions is seeking a highly motivated individual with a pharmaceutical client in the Boston, MA area. This individual will provide technical support and oversight for internal downstream manufacturing including tech transfer support.

*Project may allow hybrid-remote support.

Direct Involvement Opportunities:

  • Perform and manage technology transfers for internal downstream manufacturing.
  • Perform gap assessments, identify risks, and develop risk mitigation strategies to ensure robust phase appropriate processes for clinical trial materials.
  • Work collaboratively/align within department to assure that downstream processes are of the quality and Phase appropriate development status required for their intended use and stage of development, incorporating internal quality and technical standards, as well as aligning with cGMP and other drug regulatory requirements.
  • Establish downstream strategies, specifications, and manufacturing norms.
  • Responsible for providing key downstream manufacturing technical content of Quality Systems documents (batch records, SOPs, deviations, validation reports, etc.).

Qualifications, Skills, And Experience:

  • Bachelor or advanced degree in Biochemical, Chemical Engineering or a related scientific discipline such as Chemistry or Biology.
  • Minimum of 7+ years’ relevant experience.
  • Must have cGMP pharmaceutical MSAT or technical services, technology transfer, or process experience.
  • Should have strong understanding pertaining to filtration and/or purification equipment and processes.
  • Strong interpersonal and communications skills; written and oral.
  • Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects.
  • Knowledge of data management tools and statistical process controls is preferred.