Bristol Myers Squibb Manufacturing Operational Engineer in Devens, Massachusetts
Major Job Duties and Responsibilities:
-Monitors process data and reviews trends.
-Works with MS&T as key interface to analyze and communicate pertinent data and represents Manufacturing at all SPC related meetings.
-Facilities cross functional discussions on process issues and enhancements and develops/executes resolutions.
-Works with Project leads and cross functional teams on platform technology and new technology implementation/introduction.
-Frequently interacts with area management, outside customers and functional peer groups across various departments.
Acts as Manufacturing representative for site assessment for new products entry in partnership with MS&T and ME groups ( as well as Manufacturing Technical Leads).
Acts as Manufacturing representative in cross functional teams (in conjunction with Mfg Engineering and MS&T groups) to: determine facility fit requirements for new product introduction design, procure and implement capabilities required for successful new product introduction and validation.
Work with MS&T to develop harmonized business processes and tools related to technical transfer across sister sites (Devens, Syracuse, Cruiserath).
Change control follow through – provides training to shift personnel and communication of progression and key changes information
Act as Supervisor for complex investigations.
Acts as Manufacturing representative/interface with Mfg Enginering to design equipment to support process requirements
Authors, reviews and approve CAPAs, Procedures policy and instructions, validation reports, automation recipes.
Supports investigations closure through review and approval for manufacturing area.
SMEs for training module development /modification for equipments and new operations.
Drive implementation of new technology-hardware/software in conjunction with manufacturing technology team.
Act as SME in procurement of equipment/instruments for the functional area.
Work in collaboration with Engineering , Mfg Technology and/or Technical Services to review/approve specifications and provide user requirements.
Develop new equipment SOPs and support URS/FS review. Act as project manager/facilitator for continuous improvement initiatives.
Knowledge and Skill:
B.S. in science, engineering or related discipline is required.
A minimum of 6+ years process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
Extensive knowledge in multiple facets of biologics technical development, manufacturing and quality
Mastery of SOPs and cGMPs and the know–how to work and manage within a regulatory environment.
Extensive knowledge of pharmaceutical and biopharmaceutical manufacturing process with a proven record in pharmaceutical technology, technology transfer, process development, manufacturing support.
Demonstrated ability to successfully manage multiple functions and activities, including people, financials, business processes, and projects and to provide focus, direction and prioritization to navigate in a fast paced environment.
Demonstrated ability to drive for results and lead innovation and change
Excellent leadership skills with the ability to motivate and manage a team with dotted-line reporting relationship (ie, leading through influence)
Adaptable to a fast paced, complex and ever changing business environment.
Effective communication skills with support groups in the coordinating system to obtain needed cooperation and support as required in a timely and effectively manner.
Experience in lean mythology and proven record for driving improvements
Effective verbal and writer communication skills with technical writing skills.
Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment.
Proficiency with Syncade and DeltaV and experience with Aegis Discoverant, Trackwise, Maximo, and SAP preferred
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.