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.
MSAT Process Engineer (cGMP Pharmaceutical)
Portsmouth, NH, MA areas
AM Technical Solutions is seeking a highly motivated individual with a pharmaceutical client in the MA and NH areas. This individual will draft and review protocols, production procedures, and process development reports, and provide technical assessment and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements.
Direct Involvement Opportunities:
- Lead process-related deviations and provide technical support to manufacturing.
- Process Transfer and Process Support: Perform all functions associated with process transfer and process support, e.g. develop process understanding, perform gap analysis/FMEA, generate process models, author/review process descriptions and batch records.
- Author/review planned deviations and change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release (assess deviations and process changes).
- Investigate, identify root-cause for critical deviations and determine CAPA for manufacturing.
- Write product impact assessments to support deviations.
- Write and review technical documentation (electronic batch records, SOPs, protocols, and reports).
- Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, and investigating, and troubleshooting equipment and process issues.
- Design and execute process development studies to develop a thorough understanding of operating and performance parameters.
- Support cross-functional technology transfer teams for cGMP.
Qualifications, Skills, And Experience:
- Bachelor or advanced degree in Biochemical, Chemical Engineering or a related scientific discipline such as Chemistry or Biology.
- Minimum of 5+ years relevant experience.
- Must have cGMP pharmaceutical MSAT or technical services, technology transfer, or process development experience. Strong upstream cell culture experience also preferred.
- 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 cell and gene therapy vector production is highly desirable.
- Knowledge of data management tools and statistical process controls is preferred.