Manager, Commissioning & Qualification Engineer
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.
- Partners with Project Execution & Site Operations teams to ensure successful project handover through start-up and operations.
- Influences C&Q resource planning, coordination and interdependencies to support the Capital Program.
- Participate/lead regulatory surveillance and benchmarking initiatives with peers externally to stay abreast of changes in regulations that affect impacted processes and also to identify new ways of working and evolving technologies in this space
- Provide leadership, coaching, and training for Community of Practices (COP) including both the technical processes and the behaviors necessary to optimize process execution
- Author Facility Design Quality Directives/Engineering Standards
- Liaise with Quality Leadership Team and other functional leaders to identify and empower Community of Practices (COP) members
- Collaborate with the Computerized System Validation team
- Support Sites with Internal and External cGMP Audit Findings
- Influence Service Partners through Design Stages
- Provide Peer Review for key project designs
- Utilizes communication and persuasion skills and leads by example.
- Maintains global expertise through ongoing training and participation in industry forums
Experience / Knowledge Desired:
- Significant Commissioning & Qualification experience in Advanced Therapy Medicinal Products (ATMPs)/Biologics/Pharmaceutical/R&D projects.
- Working understanding of lean processes principles.
- Comprehension of Industry and Regulatory Authorities Regulations related to Biopharmaceutical Facilities including FDA, EMA, ASTM, ISPE, AALAC, etc.
- Familiarity with ICH 10 and ASTM E2500 processes.
- Minimum of 7 years' experience with projects in a regulated industry (i.e. GxP manufacturing / supply chain / research and development) with a broad based understanding of pharmaceutical manufacturing and overall business processes.
- Excellent planning, organizing, analysis and problem solving skills. Strong background and understanding in the planning and execution of projects.
- Familiarity with Commissioning and Qualification Processes, Tools & Systems utilized within the industry.
- Demonstrated business acumen, understanding of business needs, risks and regulatory implications in the development/assessment of design alternatives
- Ability to work in a fast-paced environment, organized and able to prioritize tasks to meet multiple deadlines.
- Ability to use discretion with sensitive/confidential information
- Demonstrated proficiency with standard Project Management tools (MS Project, Excel, Visio, SharePoint, PowerPoint) and templates
Excellent interpersonal, verbal and written communication skills.
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.