Lead Responsible Engineer supporting GMP clean utilities and systems for the Cambridge Site (HVAC, WFI, PW, gases, cold rooms, refrigerators, and freezers). Direct and coordinate the efforts of other resources including two direct report engineers, and support groups from other departments and outside the company. Supervisory responsibility for staff including setting performance goals and objectives and review of performance. Maintain validated state of equipment by following the defined change control system, specifying required validation activities, and overseeing annual revalidation efforts. Respond to system related issues with the goal of maintaining compliant operations and minimizing impact to production. Charter and lead continuous improvement efforts. Create and maintain relationships with other sites to develop and promote best practices. Work with Facilities Engineering group to specify and implement modifications to improve operational performance and compliance. Uphold, define, and police safety procedures and safe practices.
- Experience in managing staff (line or cross functional) in the execution of technical projects or other medium term initiatives.
- Experience with Regulatory and GMP requirements for operating a licensed biologics facility.
- Experienced with operations and maintenance of a large complex GMP utilities (PW, WFI, Clean steam) and HVAC/HEPA
Minimum BS w/7 or MS w/5 years experience.