Engineer, Manufacturing Support
Full time @Bristol-Myers Squibb in Pharmaceuticals Shortlist Email JobJob Detail
-
Job ID 3191
-
Career Level Others
-
Experience 2 Years
-
Qualifications Master’s Degree
Job Description
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Employer: Bristol-Myers Squibb Company
Position: Engineer, Manufacturing Support (Re#: 1610)
Location: 38 Jackson Road, Devens, MA 01434
Duties: Provide technical oversight associated with the transfer and manufacture of drug substance designated for clinical/launch by utilizing experience with SOPs, cGMP, regulatory environment, design, control and operation of biologics unit operations, investigating process deviations and developing issue and resolving CAPAs (Correction Actions and Preventive Actions) and execution and management of process technical transfer. Lead the technical transfer and scale-up of biological processes from process development into clinical and commercial manufacturing. Oversee and author facility fit reports and schedule adherence to each aspect of the tech transfer. Provide 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. Support of health authority and internal audits. Identify and assist in the implementation of new technologies from Development into Operations. Lead continuous improvement projects. Responsible for process and equipment change controls. Support processing via in-plant coverage and troubleshooting process upsets, as well as identify opportunities for process improvements. Provide required technical guidance for SOPs required for manufacturing. Compile data from manufacturing, performing statistical analysis to trend and track process performance, culminating in campaign summary. Review and approve single-use consumable drawings required for the manufacturing facility. Participate 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, 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.
Requirements: Master’s degree in Biological Science, Chemical/Biochemical Engineering or a related filed plus 2 years of post-baccalaureate experience reflecting demonstrable ability in the skills set described above.
In lieu of Master’s degree in Biological Science, Chemical/Biochemical Engineering or a related filed plus 2 years of post-baccalaureate experience reflecting demonstrable ability in the skills set described above, the employer will accept a Bachelor’s degree in Biological Science, Chemical/Biochemical Engineering or a related filed plus 4 years of post-baccalaureate experience reflecting demonstrable ability in the skills set described above.
** This position is eligible for our employee referral program
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
