Bristol Myers Squibb Engineer, Manufacturing Support in Devens, Massachusetts
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.
B.S. in the biological sciences or chemical/biochemical engineering, or related discipline with a minimum of 6 years relevant experience in the biopharmaceutical industry., or its equivalent.
M.S., in the biological sciences or chemical/biochemical engineering, or related discipline with a minimum of 4 years relevant experience in the biopharmaceutical industry., or its equivalent.
PH.D., in the biological sciences or chemical/biochemical engineering, or related discipline.
Mastery of SOPs, cGMPs and the know how to work within a regulatory environment.
Proven experience in successful execution and management of process technical transfer.
Experience in the design, control and operation of biologics unit operations (upstream or downstream).
Strong Experience in investigating process deviations and developing issue resolving CAPAs.
Experience leading cross 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.
Leads the technical transfer and scale-up of biological processes from process development into clinical / commercial manufacturing.
Oversees and authors facility fit reports and schedule adherence to each aspect of the tech transfer.
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 crossfunctional teams to forecast and procure required raw materials.
Support of health authority and internal audits
Identifies and assists in the implementation of new technologies from Development into Operations.
Leads continuous improvement projects
Responsible for process and equipment change controls.
Supports processing via in-plant coverage and troubleshooting process upsets, as well as identify opportunities for process improvements
Provides required technical guidance for SOP’s required for manufacturing.
Provides required technical guidance and approval for manufacturing batch records.
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.
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.
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.
Company: Bristol Myers Squibb
Req Number: R1528887-en-us
Updated: 2020-11-25 02:55:16.648 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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