Aseptic Associate Manufacturing Engineer (R1555507-en-us)
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.
The Aseptic Associate Manufacturing Engineer within the Upstream Technical Manufacturing team will be the subject matter expert (SME) for the aseptic operations within the manufacturing process, including cell bank, inoculum scale up and ISO 5 final fill operations. The Aseptic Associate Manufacturing Engineer will represent Manufacturing as the subject matter expert on various projects and cross-functional teams. This includes leading process, engineering, and documentation improvement opportunities, as well as participating as the manufacturing representative on larger capital projects and Project Management Office (PMO) governed initiatives. The Aseptic Associate Manufacturing Engineer will support inoculum and ISO 5 final fill deviation investigations as the manufacturing SME as part of an investigation team. The Aseptic Associate Manufacturing Engineer will work closely with manufacturing personnel to identify opportunities for improvement, identify best practices, ensure changes are well understood, and provide technical training. The Aseptic Associate Manufacturing Engineer will work closely with the Technical Manufacturing Planning group to plan and schedule aseptic operations. The Aseptic Associate Manufacturing Engineer will also be the site lead for cell bank operations.
- Responsible for creating an environment for Manufacturing to execute with excellence.
- Participate in manufacturing operational and equipment improvement initiatives from conception to implementation in order to improve cadence, simplify operation and improve compliance.
- Identify process improvement opportunities and implement process changes and improvements through quality systems.
- Support MFG shift operations, Tech Transfers, Process Improvements, and other teams as required.
- Managing Manufacturing department aseptic technique qualifications.
- Develop and execute training materials for new processes and equipment.
- Seek out process inefficiencies and implement solutions.
- Strong technical operational knowledge of the upstream and/or downstream operational unit.
- Strong understanding of cGMP and regulatory agency requirements.
- Demonstrated experience in solving complex technical issues in Biologics manufacturing.
- Possess the skills and understanding to troubleshoot process equipment and the overall manufacturing process.
- Demonstration of successful participation on diverse work teams where combined contribution, collaboration and results were expected.
- Excellent written and verbal skills and the ability to provide direction and communicate expectations to the operating staff.
- Strong computer skills and proficient in Microsoft Office Suite.
- Ability to work off-hours as needed to complete projects or key tasks requiring SME oversite.
- Adaptable to a fast paced, complex and ever-changing business environment.
- Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is highly desired
- Direct biologic manufacturing experience of 3+ years
- Extensive knowledge of SOPs and GMPs and the know-how to work and manage within a regulated environment
Strong knowledge of biopharmaceutical manufacturing processes
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.