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Reporting to the Manager of Upstream Devens Manufacturing Technology, the Associate Engineer, Manufacturing Technology is to serve as a process technical expert to large scale cell culture and harvest unit operations for the commercial manufacture of biopharmaceuticals at Devens. This position offers the opportunity to provide highly visible technical leadership to resolve complex problems while meeting quality, schedule, and cost objectives. The successful candidate will be a key contributor in a dynamic and highly collaborative team environment. The candidate will set appropriate objectives and priorities, overcome obstacles; and deliver results within project timelines. Expertise and experience in the design, control, and operation of large scale inocula, seed train, bioreactor, filtration and centrifugation unit operations are highly desired. Demonstrated skills in cross-functional partnerships, supporting crossfunctional teams and knowledge of regulatory and cGMP requirements are required.
- May act as upstream lead, Manufacturing Technology during absence of Senior Engineer, Upstream.
- Provides technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs,
process improvements, review and approval of change controls.
- Supports commercial manufacturing via in-plant coverage and real-time process upset troubleshooting.
- Evaluates process performance through statistical analysis with recommendations generated for process enhancement.
- Liaises with network technical product team sub-functions as Devens site representative.
- Supports upstream aspects of process technology transfer and process validation through individual technical contribution.
- Supports the preparation of CMC documentation for regulatory filings and responses for the BMS-Devens commercial manufacturing facility.
- Provides interface as supporting process subject matter expert during regulatory inspections.
- BS in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent.
- BS or equivalent with 2-4 years relevant experience, MS or equivalent with 0-2 years relevant experience.
- Proficiency of SOPs, cGMPs and the know how to work and manage within a regulatory environment.
- Experience in successful execution and management of process technical transfer.
- Experience in designing and executing process and equipment validation plans.
- Experience in the design, modification and optimization of biologics cell culture unit operations.
- Experience in investigating process deviations and developing issue resolving CAPAs.
- Proven project management skills and effectively balancing project assignments with other duties.
- Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors.
- Excellent verbal & written communications skills.
- Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
- Principal assignment is in a modern LSCC building which requires adherence to various Personal Protective Equipment (PPE) standards.