Bristol-Myers Squibb Company

Lead Validation Engineer

Location
Devens, MA, United States
Posted
Aug 17, 2019
Ref
R1517466
Required Education
Bachelors Degree
Position Type
Full time
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.

Responsibilities:
  • Responsible for leading and/or implementing the design, implementation and maintenance of a robust cleaning validation lifecycle for process equipment and systems, that includes a bench-scale cleaning program, an efficient cleaning validation philosophy, a cleaning monitoring program, and a cleaning verification changeover program for a fully automated, multi-product biologics manufacturing facility.
  • Provides technical leadership and strategies for installation, operational and performance qualification (IQ/OQ/PQ) of area specific process equipment, validation of SIP/CIP processes, qualification of environmental chambers and qualification of critical process utility systems.
  • Provides Single Point of Contact (SPOC) and System Ownership of all validation activities for a specific manufacturing area (Production Support, Cell Culture, Purification, and Critical Utilities), working with designated peers to create a team/triage environment.
  • Broad competency and demonstrated technical knowledge is required for assignment of SPOC/System Ownership. Ability to cover multiple functional areas is desired.
  • Provides high level of validation subject matter expertise (SME) not readily available from other resources and leads multi-function teams, advises operations on validation matters. Defends the associated validation testing, cleaning validation, cleaning verification and summary reports to regulatory agencies, with no oversight from Validation management.
  • Leads validation projects whose scope, regulatory visibility, schedule requirements, and complexity require leadership in establishing informed risk-based decisions and coordination with stakeholders, collaborators, and quality assurance. Leads validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing validation lifecycle programs.
  • This individual works at the highest level and collaborates with Quality Assurance, to establish appropriate, risk-based validation methodologies. Leads projects while serving as an individual contributor of technical work and a point of contact for project stakeholders and cross-functional team members.
  • This individual may also be required to mentor junior level staff members.
  • Provides validation subject matter expertise (SME) and contributes to multi-function teams, advises operations on validation matters, and defends their work before regulatory agencies.
  • Maintains familiarity with BMS directives and industry guidelines on qualification/validation.
  • This individual may represent Devens on cross-site teams in establishing and revising BMS directives.
  • Leads, in addition to operations support, internal compliance and/or efficiency improvement efforts within department for more complex processes.


Knowledge and Skill:
  • Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent.
  • A minimum of 8 years relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
  • Direct experience with process equipment and system qualification, sterilization qualification, critical utilities validation, cleaning validation, and temperature mapping is required.
  • Knowledge of distributed control systems and automation (GAMP) validation concepts preferred.
  • A working understanding of six sigma and lean principles suggested.
  • Demonstrated proficiency in project management, oral communication, and technical writing skills are required.
  • Possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.
  • Mastery of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the technical acumen to work and manage within a regulatory environment.
  • Ability to develop and apply new and innovative approaches to projects and processes.
  • Exhibits broad technical understanding in area discipline that enables strategic leadership.
  • Understands business needs and synthesizes solutions across functions.
  • Must be able to influence others.
  • Provides technical expertise to management and lower level professionals, providing an unusually high level of information and expertise not readily available from other sources.
  • 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.


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.