Senior Specialist, Validation Engineer II

Working with Us
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.

PRINCIPAL OBJECTIVE OF THE POSITION:

The Senior Specialist, Validation Engineer II 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.

MAJOR DUTIES AND RESONSIBILITIES:

• 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 and review the 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.
• Execute work arising from change strategy, risk assessment, testing and compliance gaps. 
• Executes portfolio of limited scope and complex validation projects under strict deadlines to ensure stakeholder success and bulk drug supply.
• Maintains familiarity on BMS directives and industry guidelines on qualification/validation.

Promotes and provides excellent customer service and support

• Regularly reviews, prioritizes, and promptly responds to end user equipment qualification and support requests.
• Provides technical support and guidance on qualification and validations issues.  Interfaces 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.
• Contributes to multi-function teams, representing validation.

Regulatory Responsibilities

• Ensure alignment with BMS directives and industry guidelines on validation and quality engineering.
• May be called upon as SME in both internal and regulatory audits.
• Responsible to contribute to the preparation for regulatory inspection readiness.
• Performs other duties as assigned.

KNOWLEDGE AND SKILL:

• Familiarity of cGMP in the pharmaceutical industry.
• Direct experience with equipment, facility, sterilization commissioning and qualification, critical utilities validation, and temperature mapping concepts is preferred.
• Knowledge of distributed control systems and automation (GAMP) validation concepts suggested.
• Knowledge in designing and implementing quality systems and validation program elements required to manage the validation lifecycle of a fully automated, multi-product, biologics / cell therapy manufacturing facility.
• 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.
• A working understanding of lean principles and six sigma process is preferred.
• Demonstrated high proficiency 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.
• Understands business needs and synthesizes solutions across functions.
• The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.
• Ability to handle difficult and unusual tasks, often using creative problem-solving.
• 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.
• Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.

QUALIFICATIONS:

• 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 3+ years relevant experience with process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in an FDA regulated manufacturing facility.
• Minimum of 2+ years’ experience in equipment, facility, or utility qualification.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Devens - MA - US: $92,540 - $112,136

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
 

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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.

Supporting People with Disabilities

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.

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1601122 : Senior Specialist, Validation Engineer II