Associate Manufacturing Engineer - Downstream

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 primary role of the Associate Manufacturing Engineer is to provide advanced documentation, equipment, investigative, and process support to the manufacturing organization. The Associate Manufacturing Engineer will be the Manufacturing representative on various projects and cross functional teams (include network project teams), will provide training, participate and/or lead in the implementation of new equipment and processes, author Change Control, BOM, and SOP/MBR changes. The Associate Manufacturing Engineer will execute lean and 6-sigma manufacturing improvements.

Key Responsibilities:

• Authoring of equipment and facility change controls, MBR revisions, and CAPA Action Plans
• Process and equipment support and troubleshooting
• Author, revise and approve critical Manufacturing documentation; i.e. MBRs, BOM, and SOPs
• Project validation support and execution
• Support Lean OpEx initiatives that align with site strategy
• Seek out process inefficiencies and implement solutions
• Development and execution of training materials for new processes and equipment in conjunction with the site technical training team
• Support of MFG shift operations, Tech Transfers, Process Improvements, global network projects and other teams as required
• Lead Manufacturing process improvement projects and interact with cross-functional groups to achieve departmental and organizational goals
• Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.

Key Competencies:

• The position requires a strong understanding of cGMP and regulatory agency requirements and strong technical operational knowledge of the upstream and/or downstream operational unit
• Incumbents must have demonstrated experience in solving complex technical issues in Biologics manufacturing, and have the skills and understanding to troubleshoot process equipment and the overall manufacturing process
• The role requires demonstration of successful participation on diverse work teams where combined contribution, collaboration and results were expected
• The position requires excellent written and verbal skills and the ability to provide direction and communicate expectations to the operating staff
• The candidate will have strong computer skills and be proficient in the following programs: Word, Excel, Visio, and Project
• The position requires the ability to work off-hours as needed to complete projects or key tasks requiring SME oversite

Education/Experience

• Advanced knowledge of biological or chemistry sciences 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 4+ years
• Extensive knowledge of SOPs and GMPs and the know-how to work within a regulated environment
• Strong knowledge of biopharmaceutical manufacturing processes
• Adaptable to a fast paced, complex and ever-changing business environment
• Effective verbal and written communication skills with technical writing skills
• Proficiency in the use of computers and business software applications

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.