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Position: Senior Manager Cleaning Validation

Location: Devens, MA

Key Responsibilities:

• Provide strategic oversight and management of the cleaning validation program, ensuring alignment with regulatory requirements and industry best practices.
• Develop, write, and execute cleaning validation protocols, reports, and risk assessments.
• Establish acceptance criteria and sampling plans for cleaning verification and validation.
• Delegate tasks and coordinate the execution of cleaning studies, ensuring timely and effective completion.
• Optimize and update cleaning validation strategies and procedures to reflect current industry standards and regulatory expectations.
• Perform swab and rinse sampling, cleanability, degradation and sampling recovery studies reviewing analytical results against acceptance limits.
• Support investigations related to cleaning failures, deviations, and non-conformances.
• Collaborate with Manufacturing, Quality, and Laboratory teams to ensure validated state of cleaning processes.
• Ensure compliance with regulatory guidelines (FDA, EMA, cGMP, ICH) and internal SOPs.
• Participate in audits and inspections, providing subject matter expertise in cleaning validation.
• Maintain up-to-date knowledge of industry best practices and regulatory expectations for cleaning validation.
• Lead and support projects involving new product introductions, equipment changes, or process improvements related to cleaning.
• Author and revise Standard Operating Procedures (SOPs) related to cleaning validation and verification activities.
• Regular collaboration with Manufacturing, Quality Assurance, QC Laboratory, Engineering, and Validation teams.
• May interact with regulatory inspectors, third-party laboratories, consultants, and equipment/cleaning agent vendors.
• Based in a GMP-regulated manufacturing or laboratory environment.
• May require working in cleanrooms and controlled environments with appropriate gowning and PPE.
• Occasional requirement to work evenings, weekends, or during production shutdowns to support validation activities.
• Some travel may be required to support multi-site projects or audits.
• Determines appropriate cleaning validation approaches based on regulatory requirements, risk assessments, and product/equipment needs.
• Exercises judgment in troubleshooting cleaning validation failures and recommending corrective actions.
• Provides input into and makes decisions related to new equipment, cleaning agents, or cleaning procedures.
• Ensures decisions balance compliance, product safety, and operational efficiency.
• This position is largely self-directed, receiving high-level goals from incumbent’s supervisor. This position exercises considerable latitude in execution of responsibilities and tasks. The incumbent must make decisions independently and demonstrate flexibility to balance shifting priorities while handling large increases in workload.

Qualifications & Experience:

• Bachelor’s degree in engineering or related discipline required; advanced degree preferred.
• 8+ years of experience in cleaning validation, process validation, or a related GMP environment (pharmaceutical, biotechnology, or medical device industry).
• Hands-on experience executing validation protocols, supporting routine lifecycle maintenance, and responding to compliance requirements.
• Strong knowledge of cGMP, FDA, EMA, and ICH cleaning validation requirements.
• Experience with analytical methods such as HPLC, TOC, or microbiological techniques is preferred.
• Demonstrated ability to manage and optimize cleaning validation programs.
• Strong technical writing and documentation skills.
• Excellent problem-solving, analytical, and communication skills.
• Proven ability to execute, delegate tasks and oversee execution of cleaning studies.
• Ability to work independently as well as collaboratively in a cross-functional team.

If you come across a role that intrigues you but does not 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.

#BMSBL, BMSBLDMA

“GPS_2025”

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.

Compensation Overview:

• Devens
• MA - US: $139,460 - $168,992

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.

R1595510 : Senior Manager Cleaning Validation