Bristol Myers Squibb Associate Engineer, Manufacturing Support in Devens, Massachusetts
Reporting to the Manager, Manufacturing Support Devens Clinical Manufacturing, the Associate Engineer, Manufacturing Support is responsible for supporting the transfer and manufacture of drug substance designated for clinical/launch. The successful candidate will provide technical support for Upstream and Downstream operations. The successful candidate will be a key contributor to a dynamic and highly technical team of engineers by working with their manager to set appropriate objectives and priorities, overcoming obstacles, and delivering results within project timelines and will build and maintain effective collaborations with all site support teams. This position is Monday through Friday, first shift, but requires on-call availability in support of coverage for 24/7 manufacturing operation.
Supports the technical transfer and scale-up of biological processes from process development into clinical / commercial manufacturing.
Authors facility fit reports and schedule adherence to each aspects of the tech transfers.
Provides technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls
Responsible for interacting with cross-functional teams to forecast and procure required raw materials.
Assists in the implementation of new technologies from Development into Operations.
Supports processing via in-plant coverage and troubleshooting process upsets, as well as identify opportunities for process improvements
Compiles data from manufacturing, performing statistical analysis to trend and track process performance, culminating in campaign summary.
Reviews and approves single-use consumable drawings required for the manufacturing facility.
Assists in the review and approval for manufacturing batch records.
Actively participates in an environment which fosters safety, quality and continuous improvement in cost and customer service.
Support Maintenance activities, including review and approval of Preventative maintenance (PM), drawing updates, and support of out of Specification investigations related to Calibration of critical equipment.
Support future capital projects from start to finish, including defining user requirements, supporting installation, commissioning, and Validation activities ensuring equipment functions to current User requirement specifications.
B.S. in the biological sciences or chemical/biochemical engineering, or related discipline with 2 years relevant experience in the biopharmaceutical industry, or its equivalent.
M.S., in the biological sciences or chemical/biochemical engineering, or related discipline.
Proficiency of SOPs, cGMPs and the know how to work and manage within a regulatory environment.
Experience in successful execution of process technical transfer is desirable.
Experience in the design, control and operation of biologics unit operation (upstream or downstream).
Experience in investigating process deviations and developing issue resolving CAPAs is highly desirable.
Experience in project management skills that include collaborating in functional teams and effectively balancing project assignments with other duties.
Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to lead people and multi-disciplinary teams.
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.