Manufacturing Technology Engineering Manager
About the Job
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
The Manufacturing Technology Engineering Manager will champion process equipment within Manufacturing Operations (upstream and downstream processing, the cryogenics facility, as well as materials management) and will drive process improvements through equipment projects, equipment-related investigations and devise process equipment strategies to support robustness in manufacturing. The position reports to the Associate Director, Manufacturing Technology - Syracuse.
- Champion process equipment and process equipment improvements and drive equipment robustness within manufacturing.
- Lead and coach Quality Investigation teams to determine root causes for process equipment deviations.
- Author, champion, review, and evaluate change controls for process equipment.
- Monitor and track the impact of equipment on process performance, analyze data to identify improvements, and implement robust solutions.
- Author protocols and final technical reports for process equipment studies. Review and approve cGMP documentation as required.
- Lead cleaning and mixing validation strategy for the Syracuse site. Be accountable for protocols and reports and drive study execution in manufacturing.
- Collaborate closely with the process experts in Manufacturing Science & Technology to ensure alignment between the process expectations and equipment capabilities. Represent equipment/process strategy on capital project teams and interface with scheduling and other engineering functions.
- Align with network partners on process analytical technology, capital strategies and equipment-related aspects of technical transfer.
- Participate in network-wide alignment and optimization of Manufacturing Technology business processes.
Specific Knowledge, Skills, Abilities, etc.\:
- Experience should include technical support of a cGMP Biologics manufacturing facility, including strong knowledge and engineering leadership for drug substance processing equipment.
- Demonstrated problem solving ability, in-depth and broad experience with manufacturing systems and equipment, interpersonal, oral and written communication skills, strong leadership skills, Operational Excellence experience and the ability to interact with and lead diverse groups and teams are essential. Proven project management skills that include leading cross-functional teams and effectively balancing project assignments with other duties are desired.
- Strong technical writing and data presentation abilities are requirements.
- Experience with regulatory agency inspections and regulatory responses is a plus.
- The successful candidate will have a PhD in Chemical or Biochemical Engineering or a related discipline with 2+ years of relevant experience, an MS with 5+ years relevant experience, or a BS with 8+ years relevant experience
- This position is primarily an office-based role and requires repetitive use of hands and wrist (computer work) and infrequent lifting of items not to exceed 50 lbs. Occasional bending, twisting, and stooping to allow for gowning into classified environment required.
- This position is primarily office based with occasional work in a classified GMP manufacturing environment. Work will take part both individually and as part of a group.
- This position requires up to 5% of travel
- The position will manage and lead a team of 4 engineers with potential to add contingent workers and other positions to the team. The position is responsible for career development of this team and must also lead the safety culture of the group.