Senior Process Engineer, Cell Therapy - 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 Summary
The Sr. Process Engineer provides technical support to the Devens Cell Therapy Facility (CTF) Manufacturing processes in a GMP environment. Technical support includes troubleshooting process and equipment related issues that occur during the Manufacturing process. The Sr. Process Engineer works closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identifies root cause, and implements long-term preventive actions. Other responsibilities includes participation in process tech transfer and incoming process changes, communicate the changes to applicable departments, and lead the process improvement projects at the site. The Sr. Process Engineer works to identify and drive continuous improvements to the manufacturing process. In the future, this position will lead a small team that supports 24/7 cell therapy operations.
Key Responsibilities
• Functions as a technology and process subject matter expert
• Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing
• Facilitates deviation prevention and deviation closure through site quality systems
• Analyzes and summarizes manufacturing data to support impact assessments and investigations
• Owner of change controls for process and procedure changes
• CAPA owner for Manufacturing improvements
• Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records
• Leads technology transfer efforts for new processes and product implementation
• Trains and supports GMP operators on new procedures, processes and changes
• Applies continuous improvement tools to identify and close procedural and compliance gaps
• Identifies opportunities for process improvements and operational efficiencies, and lead implementation efforts.
• Represents MSAT and interface with other functions such as Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering
• Supports equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements and participating on impact assessments
• Ability to perform gowning activities and enter the manufacturing plant. Exposure to strong magnetic fields is commonplace in the manufacturing areas.
• Support to establish and track performance metrics for the team.
• Provides leadership and guidance to manufacturing support team as needed.
Leadership
• Creates an environment of teamwork, open communication, and a sense of urgency
• Supports the change agent in promoting flexibility, creativity, and accountability
• Supports organizational strategic goals and objectives that are linked to the overall company strategy
• Drives strong collaboration within the plant and across the network
• Builds trust and effective relationships with peers and stakeholders
• Delivers business results through timely and quality decision making and advice
• Fosters a culture of compliance and strong environmental, health, and safety performance
Education & Experience
• BSc and/or MSc degree in Science or Chem/Bio Engineering
• Minimum 8 years of industry experience. Cell Therapy manufacturing experience preferred.
• Minimum 6 years relevant experience in GMP biologic manufacturing technical or process support.
Preferred Qualifications:
• 1+ years managing direct report
• Experience with Operational Excellence and Lean Manufacturing.
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: R1583975
Updated: 2024-09-26 01:59:02.110 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 Summary
The Sr. Process Engineer provides technical support to the Devens Cell Therapy Facility (CTF) Manufacturing processes in a GMP environment. Technical support includes troubleshooting process and equipment related issues that occur during the Manufacturing process. The Sr. Process Engineer works closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identifies root cause, and implements long-term preventive actions. Other responsibilities includes participation in process tech transfer and incoming process changes, communicate the changes to applicable departments, and lead the process improvement projects at the site. The Sr. Process Engineer works to identify and drive continuous improvements to the manufacturing process. In the future, this position will lead a small team that supports 24/7 cell therapy operations.
Key Responsibilities
• Functions as a technology and process subject matter expert
• Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing
• Facilitates deviation prevention and deviation closure through site quality systems
• Analyzes and summarizes manufacturing data to support impact assessments and investigations
• Owner of change controls for process and procedure changes
• CAPA owner for Manufacturing improvements
• Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records
• Leads technology transfer efforts for new processes and product implementation
• Trains and supports GMP operators on new procedures, processes and changes
• Applies continuous improvement tools to identify and close procedural and compliance gaps
• Identifies opportunities for process improvements and operational efficiencies, and lead implementation efforts.
• Represents MSAT and interface with other functions such as Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering
• Supports equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements and participating on impact assessments
• Ability to perform gowning activities and enter the manufacturing plant. Exposure to strong magnetic fields is commonplace in the manufacturing areas.
• Support to establish and track performance metrics for the team.
• Provides leadership and guidance to manufacturing support team as needed.
Leadership
• Creates an environment of teamwork, open communication, and a sense of urgency
• Supports the change agent in promoting flexibility, creativity, and accountability
• Supports organizational strategic goals and objectives that are linked to the overall company strategy
• Drives strong collaboration within the plant and across the network
• Builds trust and effective relationships with peers and stakeholders
• Delivers business results through timely and quality decision making and advice
• Fosters a culture of compliance and strong environmental, health, and safety performance
Education & Experience
• BSc and/or MSc degree in Science or Chem/Bio Engineering
• Minimum 8 years of industry experience. Cell Therapy manufacturing experience preferred.
• Minimum 6 years relevant experience in GMP biologic manufacturing technical or process support.
Preferred Qualifications:
• 1+ years managing direct report
• Experience with Operational Excellence and Lean Manufacturing.
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: R1583975
Updated: 2024-09-26 01:59:02.110 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