Manager, Cleaning Validation • Validation Engineering - Bristol Myers Squibb
Devens, MA
About the Job
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 rich in diversity. 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: Manager, Cleaning Validation, Validation Engineering
Location : Devens, MA
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 rich in diversity. 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 Summary
Manage the development and maintenance of the cleaning validation and changeover cleaning verification program elements for a fully automated, multi-product, biologics manufacturing facility to assure readiness for intended use and to meet all policy and compliance requirements.
Key Responsibilities
+ Responsible for implementing the design, implementation and maintenance of a robust cleaning validation lifecycle for process equipment and systems, that includes a bench-scale cleaning program, an efficient cleaning validation philosophy, a cleaning monitoring program, and a cleaning verification changeover program for a fully automated, multi-product biologics manufacturing facility.
+ Establish and implement the cleaning validation philosophies and master plans required to drive the cleaning validation lifecycle.
+ Responsibilities include oversight of cleaning 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.
+ Responsible for regulatory inspection readiness and guidance to ensure cleaning validation and cleaning verification changeover philosophies are well understood.
+ Manage multiple projects.
+ Work collaboratively with peers within the Validation Execution function, Manufacturing Systems, Information Technology, Manufacturing, Manufacturing Engineering and Quality
+ Effectively manage workload to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
+ Ensure alignment with BMS directives and industry guidelines on cleaning validation and quality engineering.
+ Leads and/or executes validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing validation lifecycle programs. This individual works at the highest level and collaborates with Quality Assurance, to establish appropriate, risk-based validation methodologies.
+ Provides validation subject matter expertise (SME) and contributes to multi-function teams, advises operations on cleaning validation matters.
+ Supports internal compliance and/or efficiency improvement efforts within department for more complex processes.
Qualifications & Experience
+ Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience.
+ A minimum of 6 years relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
+ Experience with process equipment and system qualification, steaming/sterilization qualification, cleaning validation, and multi-product changeover requirements.
+ Experience in designing cleaning program elements, steaming/sterilization program elements, bench-scale studies to support cleaning and implementation of supporting quality systems required to manage the cleaning cycles and changeover program of a fully automated, multi-product, biologics manufacturing facility.
+ Experience in establishing site and program validation strategies that are aligned with current industry mindsets.
+ Understanding of the US and ex-US regulatory requirements for licensure of a multi-product biopharmaceutical facility.
+ Understanding of lean principles and establishment of effective process metrics is preferred.
+ Project management, communication, and technical writing skills are required.
+ Possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.
+ Working knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the technical acumen to work and manage within a regulatory environment.
+ Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics manufacturing.
+ Ability to develop and apply new and innovative approaches to projects and processes.
+ Must be able to influence others.
+ Demonstrated emotional intelligence required to inspire and influence the behaviors and performance of others, as well as for conflict management.
+ The flexibility required to constructively lead and encourage peers and team members to drive results in a changing environment.
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.
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 an inclusive culture, promoting diversity 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 a diverse 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.
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/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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.
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 an inclusive culture, promoting diversity 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 a diverse 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.
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/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1585322
Updated: 2024-09-27 01:55:12.786 UTC
Location: Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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 rich in diversity. 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: Manager, Cleaning Validation, Validation Engineering
Location : Devens, MA
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 rich in diversity. 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 Summary
Manage the development and maintenance of the cleaning validation and changeover cleaning verification program elements for a fully automated, multi-product, biologics manufacturing facility to assure readiness for intended use and to meet all policy and compliance requirements.
Key Responsibilities
+ Responsible for implementing the design, implementation and maintenance of a robust cleaning validation lifecycle for process equipment and systems, that includes a bench-scale cleaning program, an efficient cleaning validation philosophy, a cleaning monitoring program, and a cleaning verification changeover program for a fully automated, multi-product biologics manufacturing facility.
+ Establish and implement the cleaning validation philosophies and master plans required to drive the cleaning validation lifecycle.
+ Responsibilities include oversight of cleaning 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.
+ Responsible for regulatory inspection readiness and guidance to ensure cleaning validation and cleaning verification changeover philosophies are well understood.
+ Manage multiple projects.
+ Work collaboratively with peers within the Validation Execution function, Manufacturing Systems, Information Technology, Manufacturing, Manufacturing Engineering and Quality
+ Effectively manage workload to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
+ Ensure alignment with BMS directives and industry guidelines on cleaning validation and quality engineering.
+ Leads and/or executes validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing validation lifecycle programs. This individual works at the highest level and collaborates with Quality Assurance, to establish appropriate, risk-based validation methodologies.
+ Provides validation subject matter expertise (SME) and contributes to multi-function teams, advises operations on cleaning validation matters.
+ Supports internal compliance and/or efficiency improvement efforts within department for more complex processes.
Qualifications & Experience
+ Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience.
+ A minimum of 6 years relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
+ Experience with process equipment and system qualification, steaming/sterilization qualification, cleaning validation, and multi-product changeover requirements.
+ Experience in designing cleaning program elements, steaming/sterilization program elements, bench-scale studies to support cleaning and implementation of supporting quality systems required to manage the cleaning cycles and changeover program of a fully automated, multi-product, biologics manufacturing facility.
+ Experience in establishing site and program validation strategies that are aligned with current industry mindsets.
+ Understanding of the US and ex-US regulatory requirements for licensure of a multi-product biopharmaceutical facility.
+ Understanding of lean principles and establishment of effective process metrics is preferred.
+ Project management, communication, and technical writing skills are required.
+ Possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.
+ Working knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the technical acumen to work and manage within a regulatory environment.
+ Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics manufacturing.
+ Ability to develop and apply new and innovative approaches to projects and processes.
+ Must be able to influence others.
+ Demonstrated emotional intelligence required to inspire and influence the behaviors and performance of others, as well as for conflict management.
+ The flexibility required to constructively lead and encourage peers and team members to drive results in a changing environment.
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.
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 an inclusive culture, promoting diversity 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 a diverse 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.
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/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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.
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 an inclusive culture, promoting diversity 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 a diverse 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.
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/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1585322
Updated: 2024-09-27 01:55:12.786 UTC
Location: Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb