Bristol-Myers Squibb
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 recognises the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programmes that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Position Title and Location Senior Manager Cleaning Validation – 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.
Collaborate regularly with Manufacturing, Quality Assurance, QC Laboratory, Engineering, and Validation teams.
May interact with regulatory inspectors, third‑party laboratories, consultants, and equipment/cleaning agent vendors.
Must be 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.
Determine appropriate cleaning validation approaches based on regulatory requirements, risk assessments, and product/equipment needs.
Exercise judgment in troubleshooting cleaning validation failures and recommending corrective actions.
Provide input into and make decisions related to new equipment, cleaning agents, or cleaning procedures.
Ensure decisions balance compliance, product safety, and operational efficiency.
This position is largely self‑directed, receiving high‑level goals from the incumbent’s supervisor. It requires considerable latitude in execution and the ability to make independent decisions while balancing shifting priorities and workload increases.
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 optimise 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.
Compensation Overview Devens – MA – $139,460 – $168,992 (per year). Additional incentive cash and stock opportunities may be available. Final individual compensation will be decided based on demonstrated experience.
Benefits Summary Medical, pharmacy, dental and vision care; wellbeing support, employee assistance programmes; financial wellbeing resources including 401(K); paid national holidays and optional holidays; up to 120 hours of paid vacation; parental, caregiver, bereavement and military leave; family care services; tuition reimbursement; recognition programme, and more.
Equal Employment Opportunity Applicants can request a reasonable workplace accommodation or adjustment prior to accepting a job offer. For accommodations, contact adastaffingsupport@bms.com. BMS complies with all applicable equal employment opportunity laws. Please visit careers.bms.com/eeo-accessibility for the complete statement.
Vaccination Requirement BMS strongly recommends that all employees be fully vaccinated for COVID‑19 and keep up to date with booster recommendations.
Additional Information Applicants who live in or expect to work from Los Angeles County, if hired for this position, should visit https://careers.bms.com/california-residents/ for important additional information.
#J-18808-Ljbffr
Bristol Myers Squibb recognises the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programmes that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Position Title and Location Senior Manager Cleaning Validation – 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.
Collaborate regularly with Manufacturing, Quality Assurance, QC Laboratory, Engineering, and Validation teams.
May interact with regulatory inspectors, third‑party laboratories, consultants, and equipment/cleaning agent vendors.
Must be 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.
Determine appropriate cleaning validation approaches based on regulatory requirements, risk assessments, and product/equipment needs.
Exercise judgment in troubleshooting cleaning validation failures and recommending corrective actions.
Provide input into and make decisions related to new equipment, cleaning agents, or cleaning procedures.
Ensure decisions balance compliance, product safety, and operational efficiency.
This position is largely self‑directed, receiving high‑level goals from the incumbent’s supervisor. It requires considerable latitude in execution and the ability to make independent decisions while balancing shifting priorities and workload increases.
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 optimise 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.
Compensation Overview Devens – MA – $139,460 – $168,992 (per year). Additional incentive cash and stock opportunities may be available. Final individual compensation will be decided based on demonstrated experience.
Benefits Summary Medical, pharmacy, dental and vision care; wellbeing support, employee assistance programmes; financial wellbeing resources including 401(K); paid national holidays and optional holidays; up to 120 hours of paid vacation; parental, caregiver, bereavement and military leave; family care services; tuition reimbursement; recognition programme, and more.
Equal Employment Opportunity Applicants can request a reasonable workplace accommodation or adjustment prior to accepting a job offer. For accommodations, contact adastaffingsupport@bms.com. BMS complies with all applicable equal employment opportunity laws. Please visit careers.bms.com/eeo-accessibility for the complete statement.
Vaccination Requirement BMS strongly recommends that all employees be fully vaccinated for COVID‑19 and keep up to date with booster recommendations.
Additional Information Applicants who live in or expect to work from Los Angeles County, if hired for this position, should visit https://careers.bms.com/california-residents/ for important additional information.
#J-18808-Ljbffr