Manager, Cleaning Validation

2 weeks ago

Devens, Massachusetts, United States Bristol Myers Squibb Full time
Job Summary

Bristol Myers Squibb is seeking a highly skilled Manager, Cleaning Validation to join our team. As a key member of our Validation Engineering department, you will be responsible for managing the development and maintenance of the cleaning validation and changeover cleaning verification program elements for a fully automated, multi-product, biologics manufacturing facility.

Key Responsibilities
  • Implement a robust cleaning validation lifecycle for process equipment and systems, including a bench-scale cleaning program, an efficient cleaning validation philosophy, a cleaning monitoring program, and a cleaning verification changeover program.
  • Establish and implement cleaning validation philosophies and master plans to drive the cleaning validation lifecycle.
  • Oversight of cleaning validation lifecycle maintenance, including establishment of validation document hierarchy, tracking execution work arising from change controls, shutdown/changeover management related to validation, and management of the revalidation and cleaning monitoring programs.
  • Regulatory inspection readiness and guidance to ensure cleaning validation and cleaning verification changeover philosophies are well understood.
  • Manage multiple projects and work collaboratively with peers within the Validation Execution function, Manufacturing Systems, Information Technology, Manufacturing, Manufacturing Engineering, and Quality.
  • Effectively manage workload to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
  • Ensure alignment with BMS directives and industry guidelines on cleaning validation and quality engineering.
  • Lead and/or execute validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing validation lifecycle programs.
  • Provide validation subject matter expertise (SME) and contribute to multi-function teams, advise operations on cleaning validation matters.
  • Support internal compliance and/or efficiency improvement efforts within department for more complex processes.
Qualifications & Experience
  • Bachelor's degree in engineering or a related discipline, or equivalent industry experience.
  • Minimum 6 years relevant experience in a Validation role in the biopharmaceutical industry or equivalent.
  • Experience with process equipment and system qualification, steaming/sterilization qualification, cleaning validation, and multi-product changeover requirements.
  • Experience in designing cleaning program elements, steaming/sterilization program elements, bench-scale studies to support cleaning, and implementation of supporting quality systems required to manage the cleaning cycles and changeover program of a fully automated, multi-product, biologics manufacturing facility.
  • Experience in establishing site and program validation strategies aligned with current industry mindsets.
  • Understanding of US and ex-US regulatory requirements for licensure of a multi-product biopharmaceutical facility.
  • Understanding of lean principles and establishment of effective process metrics is preferred.
  • Project management, communication, and technical writing skills are required.
  • Possess the professionalism and technical competency required to represent the department before stakeholders, regulatory agencies, and management.
  • Working knowledge of SOPs, cGMPs, and compliance requirements and regulatory guidelines (FDA, EU) and the technical acumen to work and manage within a regulatory environment.
  • 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.
  • Ability to develop and apply new and innovative approaches to projects and processes.
  • Must be able to influence others.
  • Demonstrated emotional intelligence required to inspire and influence the behaviors and performance of others, as well as for conflict management.
  • The flexibility required to constructively lead and encourage peers and team members to drive results in a changing environment.

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