Senior Manager Cleaning Validation

Bristol Myers Squibb•Devens, MA

1d•Onsite

About The Position

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. 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 #LI-Onsite “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.

Requirements

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.
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.

Nice To Haves

Experience with analytical methods such as HPLC, TOC, or microbiological techniques is preferred.

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.

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.

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