Bristol-Myers Squibb Company

Associate Director, Validation Services

Location
Syracuse, NY
Posted
Jul 03, 2019
Ref
R1516528
Required Education
Bachelors Degree
Position Type
Full time
Major Duties & Responsibilities

1. Lead the qualification/validation function for a fully automated commercial Biologics Drug Substance manufacturing facility.

2. Lead functions within the Validation group responsible for installation, operational and performance qualification (IQ/OQ/PQ) of process equipment, validation of SIP/CIP processes, validation of critical process equipment & utility systems and validation of process automation systems.

3. Oversee validation execution for all engineering projects (small to large). Establish validation project plans commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with customers, collaborators, and quality.

4. Owns the overall Site Validation Master Plan.

5. Responsibilities include oversight of validation execution work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation and cleaning monitoring programs. This individual works in conjunction with Quality Assurance to establish appropriate plans and strategies aligned with site validation philosophies.

6. Responsible to deliver validation projects under strict deadlines to ensure customer success and bulk drug supply. This includes the establishment of plans, protocols, test scripts, risk assessments, and summary reports.

7. Manage multiple projects while serving as a point of contact for validation execution projects.

8. Responsible to act as a validation subject matter expert (SME), serving as the primary point of contact to present validation philosophies and strategies to Health Authority inspectors and auditors.

9. Works collaboratively with Manufacturing, Technical Manufacturing, Manufacturing Technology, Facilities & Engineering and Quality.

10. Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.

11. Ensure alignment with BMS directives and industry guidelines on validation.

12. Develops and leads a high performance team responsible for validation execution, manages the recruitment and development of staff, invests in the development of current and future leadership through assignment of development opportunities, coaching, mentoring, and effective administration of rewards and recognition.

13. Establishes and communicates high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies to reduce operational variances and reduce cycle time.

14. Responsible for ensuring all regulatory and GxP compliance items related to Validation are satisfied.

15. Provide significant regulatory inspection readiness training, coaching and guidance to junior level staff/SMEs in validation group.

16. Manage and develop staff, establish a staffing plan that includes adequate competent resourcing, hiring of key technical individuals as needed, and development and succession planning.

Knowledge and Skills
  • Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience.
  • A minimum of 12+ years directly relevant experience in validation of process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in a biologics drug substance manufacturing facility.
  • Direct experience with sterilization qualification, cleaning validation, critical utilities validation, cleaning validation, computer validation and temperature mapping concepts is required.
  • Previous managerial experience which demonstrates proficiency in selection, motivating and retaining a superior team, effectively managing personnel issues and planning and administering financial resources preferred.
  • Experience with Health Authority Inspections, External Auditors, Corporate and Internal Auditors presenting validation philosophies, strategies and executed testing.
  • Familiarity with distributed control systems and automation (GAMP) validation concepts allows this individual to participate in cross-functional validation efforts.
  • A working understanding of lean principles is preferred. Excellent project management, communication, and technical writing skills are required.
  • The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.
  • Demonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams and Standard Operating Procedures.
  • Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics manufacturing.
  • Proven ability working in a matrix environment and leading multi-level / cross functional teams to achieve the highest performance in meeting site and departmental objectives.


Contacts

The Associate Director, Validation Servicesis in direct contact with the Director, Facilities & Engineering, and other senior leaders within the site, including heads of Quality, Manufacturing, Supply Chain and Human Resources. Frequent interactions occur with Qualityand Manufacturing staff.Occasional interactions occur with external industry and regulatory representatives.

Will interact directly with Health Authorities during inspections to explain validation related inquiries, as required.

This position is largely self-directed, receiving high-level goals from incumbent's supervisor. This position exercises considerable latitude in execution of responsibilities and tasks. The incumbent must make decisions independently and demonstrate flexibility to balance shifting priorities while handling large increases in work load.

This position will supervise a team of validation engineers, scientists and in some cases contract technicians in the development, execution and summary report writing of validation protocols, test scripts, master plans, risk assessments etc. The Department will consist of both full time and contract resources (n = 10 to 12 - in normal circumstances). Number will vary based on number of projects in progress.