Bristol Myers Squibb Manufacturing Technical Specialist in Syracuse, New York
The primary role of the Manufacturing Technical Specialist is to provide advanced documentation, equipment, investigative, and process support to the manufacturing organization. The Technical Specialist will be the Manufacturing representative on various projects and cross functional teams, will provide training, participate in the implementation of new equipment and processes, author Change Control, BOM, and MBR changes, and perform low level Quality Event investigations. The Technical Specialist will execute lean and 6-sigma manufacturing improvements.
• Investigation and execution low risk Quality Events to support manufacturing operations and providing support for medium and high investigations where required.
• Authoring of minor equipment and facility change controls, MBR revisions, and CAPA Action Plans
• Process and equipment support and troubleshooting
• Revision and approval of critical Manufacturing documentation; i.e. MBRs, BOM, and Change Controls
• 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, and other teams as required
• Interact with cross-functional groups to achieve departmental and organizational goals.
• Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
• 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.
• 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 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
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, disability or protected veteran status.