Senior Manager Validation Engineering

Bristol Myers Squibb • Devens, MA

28d • Onsite

About The Position

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. Read more: careers.bms.com/working-with-us. Position: Senior Manager Validation Engineering Location: Devens, MA

Requirements

• 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.
• 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.

Nice To Haves

• 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.

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

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees