Bristol Myers Squibb Manufacturing Technology Engineer in Syracuse, New York
Champion end-to-end product improvements/assessments focused on productivity, robustness, quality, business process and safety.
Lead and author Quality Risk Assessments and GAP Assessments in accordance with cGMP Quality Risk Management best practices.
Lead, author and drive implementation of change controls.
Lead Quality Investigation teams to determine root cause. Assess product impact and identify appropriate CAPA.
Analyze the impact of equipment on process performance, collect and analyze data to identify improvements, and devise then implement robust solutions.
Author protocols and final technical reports for requested initiatives/ studies.
Support PPQ and BLA filings including on-floor support, data verification and data analysis.
Review manufacturing batch records (MBR), standard operating procedures (SOP), and other cGMP documentation, as required.
Regular and frequent on-floor observation to support and improve end-to-end manufacturing.
Follow cGMP requirements.
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 knowledge of upstream and downstream processing, cryogenics, warehousing, as well as materials management.
Experience with Quality Risk Management principles, systems and tools is required. Technical writing and data presentation abilities are also required.
Demonstrated problem solving ability, experience with manufacturing systems and equipment, good interpersonal, oral and written communication skills are essential. Operation Excellence experience and project management skills are desired.
Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors is a plus.
- The successful candidate will have a MS in Chemical, Mechanical or Biochemical Engineering or a related discipline with 3+ years of relevant experience, , or a BS with 4+ 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 may manage contingent workers and is also responsible for supporting the safety culture of the group and site.
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.