Specialist, Validation Engineer l

Bristol Myers Squibb • Devens, MA

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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. SUMMARY: The Specialist, Validation Engineer I supports the successful implementation of manufacturing, and laboratory equipment alongside facilities and utilities at multi-use sites through interaction with internal customers and external service providers. The incumbent is tasked with qualifying new equipment, facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

Requirements

• Executed smaller technical projects.
• Demonstrated effectiveness working in both a team environment as well as an individual contributor role.
• Familiarity of cGMP in the pharmaceutical industry.
• Familiarity of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics / cell therapy manufacturing.
• Demonstrated ability in project management, communication, and technical writing skills suggested.
• Experienced self-motivated individual who can handle multiple priorities to meet project team goals and timelines.
• Working knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the general understanding to work within a regulatory environment.
• Knowledge must be demonstrated through previous projects of establishing validation philosophies and regulations at a site level.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
• Strong level of problem-solving skills, verbal and written communication skills, and the ability to work independently.
• Knowledge of engineering generally attained through studies resulting in a Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, related discipline, or its equivalent is required.
• A minimum of 1+ years relevant experience (co-op or internship experience) with process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in an FDA regulated manufacturing facility.
• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting to 25lbs.
• Ability to sit, stand, walk and move within workspace for extended periods.
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.
• Ability to work safely and effectively when working alone or working with others.

Nice To Haves

• A working understanding of lean principles and six sigma process is preferred.

Responsibilities

• Maintains qualified equipment systems in compliance with policies, guidelines and procedures:
• Develops and executes validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports.
• Ensure periodic reviews and requalification is being performed in accordance with schedule.
• Supports equipment qualification and validation activities.
• Develops qualification protocols, and associated reports while adhering to a change management process.
• Author Development/Review of SOPs, WPs, test protocols, validation deliverables, plans and policies as needed.
• Responsibilities include execution of validation lifecycle maintenance that includes 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, if necessary.
• Promote and provide excellent customer service and support
• Regularly review, prioritize, and promptly respond to end user equipment qualification and support requests.
• Provide technical support and guidance on qualification and validations issues.
• Interface with customers to ensure all expectations are being met.
• Maintain a positive relationship with all team members and site customers while promoting a positive team environment.
• Contribute to multi-function teams, representing validation.
• Ensure alignment with BMS directives and industry guidelines on validation and quality engineering.
• Responsible to contribute to the preparation for regulatory inspection readiness.
• Performs other duties as assigned.

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.

What This Job Offers

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