Sr. Manager, Manufacturing Sciences and Technology (MSAT) Technical Validation
(BMS) Bristol-Myers Squibb, Bothell Washington
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
PURPOSE AND SCOPE OF POSITION:
The Manufacturing Science and Technology (MSAT) Technical Validation team at Bristol Myers Squibb is responsible for all site-specific validation activities related to facility, utilities, manufacturing, process, and QC laboratory equipment, software for standalone computerized systems, as well as aseptic processing and environmental monitoring at our Manufacturing Plant located in Bothell, WA. The Sr. Manager, MSAT Technical Validation manages a team of validation engineers, provides strategic and technical leadership, establishes site-specific validation best practices, and assures on-time completion of his/her team’s deliverables. This position reports to the Director, MSAT.
DUTIES AND RESPONSIBILITIES:
- Lead team of validation engineers with varying levels of experience from entry level to senior/principal engineer
- Establish validation best practices, validation strategy, and maintenance/management of validation processes to achieve company goals and department objectives
- Lead, develop, and implement site-specific master validation plans for the facility, utilities, and equipment
- Conduct risk assessments and validation impact assessments
- Lead validation related activities during design, build, and/or modification of the manufacturing facility
- Oversee manufacturing, process, and QC laboratory equipment qualification lifecycle including DQ/IQ/OQ/PQ, summary reports, validation deviations, change records, and periodic review.
- Direct validation activities for software associated with standalone computerized manufacturing, process, and QC laboratory equipment
- Develop and implement site-specific aseptic processing simulation and environmental monitoring process qualification strategies
- Identify, design, and implement process and system improvements
- Engage in strategic and purposeful discussions to ensure stakeholder alignment when executing validation activities
- Partner with Quality Assurance in maintaining high compliance standards
- Support Quality and IT for computer systems validation
- Interpret and relate Quality standards for implementation and review
- Provide validation expertise in support of deviations, Corrective and Preventative Actions (CAPAs), and audit findings
- Influence and review technical content within the validation and facility sections of regulatory filings
- Maintain a constant state of inspection readiness by acting as the primary contact for internal and Health Authority audits and driving audit observation corrective actions to closure
- Serve as the validation representative on cross-functional and multi-site teams
- Build and maintain effective collaborative relationships across the site and network, influencing site and network validation life cycle programs
- Provide input to revised and new validation-specific global and site-specific policies and procedures
- Exercise sound judgment and flexibility while adapting to rapidly changing priorities, challenging situations, and deadlines needed to meet business objectives
- Based on department and organization goals, establish, monitor, and drive to completion validation team’s annual goals
- Effectively motivate and mentor validation team members thereby enabling their career growth
- Retain and develop key talent through timely performance discussions, annual performance evaluations, and individual career development plans
- Establish and track validation team’s performance metrics, provide progress reports to stakeholders
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- BS/MS in Engineering or Biotechnology related field
- 10+ years relevant experience in cGMP environment for Biologics/CMC/Vaccines
- 3+ years managing direct reports with varying levels of experience
- Proven record of successfully managing validation program(s) in support of GMP operations
- Thorough knowledge of validation life cycle including 21 CFR Parts 210, 211, 11, EU Annex 11, GAMP 5, and Data Integrity as well as ICH guidelines Q8, Q9, Q10
- Experience in multiple areas of validation including facility; utilities; manufacturing, process, and/or QC laboratory equipment; software validation and data integrity, media fill/aseptic process simulation (APS); environmental monitoring performance qualification (EMPQ).
- Experience representing validation program(s) during internal as well as US- and international-specific health authority audits, particularly pre-licensure inspections (PLIs)
- Excellent organizational skills and the ability to make sound decisions when allocating resources and managing team’s priorities
- Ability to communicate clearly and professionally both in writing and verbally
- Experience with cell therapies highly desired
WORKING CONDITIONS (US Only):
Employee will work in typical office conditions (sit/stand desk, lighting, temperature, noise-level, office equipment and air quality) with occasional work in the manufacturing cleanroom for specific tasks. Ability to lift a desired weight is not needed
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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.