Brammer Bio, part of Thermo Fisher Scientific is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.
The Engineer III, CQV will report directly to the CQV Head in Cambridge. (S)he will be responsible for CQV activities for the Cambridge and Somerville facilities. Thermo Fisher VVS is a cGMP biopharmaceutical contract manufacturing and development organization (CDMO) producing gene therapy products across four U.S. locations - Cambridge, Somerville, Lexington, MA and Alachua, FL.
The Engineer III, CQV will plan and execute validation projects including working with the Thermo Fisher core teams to understand the scope of validation activities and develop schedule, budget, resource plans to meet overall project objectives. (S)he will also act as a subject matter expert supporting sites during audits and inspections as needed. (S)he will create and maintain relationships with other Brammer Bio sites to develop and promote engineering best practices and ensure compliance with Brammer Bio SOP s, safe work practices, and cGMP regulations. The position involves close collaboration with Manufacturing, EHS, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities.
Experience and Skills
- A B.S. degree in mechanical engineering, biochemical engineering, chemical engineering, electrical engineering, biology or related engineering/science field and 8 years of appropriate CQV experience in a cGMP manufacturing environment.
- Extensive knowledge of validation activities including plan and protocol generation, execution, and final report approval/closeout.
- Strong interpersonal and communication skills.
- Understanding of applicable regulatory requirements (FDA and EMA). Audit experienced is strongly preferred.
- Understanding of industry standards for commissioning and validation of facilities, utilities and process equipment for cGMP manufacturing.
- Strong understanding of ASTM E2500 CQV lifecycle model.
- Excellent technical writing skills.
- Extensive knowledge of change control and performing validation impact assessments.
- Work Hours: Monday through Friday, 8:00 AM to 5:00 PM. Requires overtime to work evenings, weekends or holidays, as required to meet project timelines.
Key skills/desired experience:
- Strong experience in equipment design, installation and start-up.
- Strong experience with performing facility qualification, including environmental monitoring (EM) testing for process cleanrooms (ISO and EU classification).
- Experience with performing utility qualification for the following systems: WFI, purified water, clean steam, process gasses, HVAC, vaporized hydrogen peroxide (VHP), Chilled Glycol, Wastes, COP, etc.
- Strong experience with performing equipment qualification for the following systems: bioreactors, depth filters, mix tanks, autoclaves, chambers, chromatography, tangential flow filtration (TFF), drug product filler/isolator, etc.
- Experience with the qualification of single use technology is desired.
- Experience with the qualification of VHP systems is desired.
- Experience with the qualification of a drug product fill line (including isolator, drug product filler) is desired.
- Strong ability to work independently
- Comfortable supporting multiple concurrent issues
Associated topics: bio, bioinformatic, biology, biomedical, biophysics, biosynthetic, hereditary, molecular, neuro, neuroscience