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Bristol Myers Squibb Senior Manager, Cleaning Validation Engineering in Devens, Massachusetts

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.

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.

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.

BMSBL, BMSBLDMA

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol Myers Squibb

Req Number: R1541153

Updated: 2021-10-20 02:33:49.418 UTC

Location: Devens,Massachusetts

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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