Senior Manager Validation Engineering

Senior Manager Validation Engineering

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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.

Key Responsibilities:

• Lead functions within the Validation Engineering group responsible for the qualification lifecycle of facility, utility, and processing equipment systems.
• Leads functions responsible for installation, operational, and performance qualification (I/O/PQ) of systems arising from projects and change controls.
• Leads the site Periodic Assessment and Requalification program by establishing procedures aligned with BMS directives and industry guidance. Ensures execution of program to predefined schedule.
• 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.
• Responsibilities include oversight of validation execution work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs. This individual works in conjunction with Validation Management peers, Validation Program management, and Quality Assurance to establish appropriate plans and strategies aligned with site validation philosophies.
• 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.
• Manage multiple projects while serving as a point of contact for validation execution projects.
• Responsible to act as a validation subject matter expert (SME), serving as the primary point of contact to present validation philosophies and strategies to Board of Health (BOH) inspectors and auditors.
• Works collaboratively with Engineering, Digital Plant, Manufacturing, and Quality.
• Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
• Ensure alignment with BMS directives and industry guidelines on validation.
• 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.
• Establishes and communicates high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies to reduce operational variances and reduce cycle time.

Qualifications & Experience:

• 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.
• This position requires a B.S. degree in a scientific, technical, or engineering discipline.
• A minimum of 6 years relevant experience with process equipment, computer systems, manufacturing process control systems (automation), and laboratory instrumentation in a biologics manufacturing facility.
• Direct experience with equipment, facility, sterilization qualification, critical utilities 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 Board of Health (BOH) Inspectors, 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.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients' lives through science", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles, the ability to physically travel to visit customers, patients, or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.

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