Specialist, Commissioning Engineer I - 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 .
The Commissioning Engineer I will be part of the Commissioning team reporting to Sr. Manager, Commissioning Engineering and support clinical and commercial Devens manufacturing facility. This position may lead contractors for complete asset life cycle onboarding oversight of commissioning and any other effort arising from design and implementation of new/modified asset(s) as part of capital projects at the Devens site. The incumbent will apply existing and new knowledge of Engineering Project Management to support multiple, high-pace projects across multiple functions as part of the commissioning phase of asset introduction and/or modifications. This position will lead, execute and assist in commissioning activities for capital projects and collaboratively develop our commissioning protocols and practices. This position is responsible for facilities, utilities, equipment and analytical instruments commissioning project activities in both GxP and non-GxP systems. This position will interface with key stakeholder groups such as, Engineering, Capital Project Management, Quality Assurance, Quality Control, Qualification, Manufacturing Engineering, Facilities operations/maintenance, Validation and Manufacturing.
Key Responsibilities:
+ Executes and/or Leads installation, commissioning activities of area specific process equipment, validation of SIP/CIP
+ processes, qualification of environmental chambers and qualification of critical and non-critical process utility systems.
+ Provides Single Point of Contact (SPOC) on all commissioning activities for a specific manufacturing area (Production
+ Support, Cell Culture, Purification, and Critical Utilities), working with designated peers to create a team/triage
+ environment.
+ Assignment of SPOC to designated manufacturing area is based on demonstrated technical knowledge and experience
+ with associated equipment/systems.
+ Lead and execute vendor qualification protocols and triage commissioning deviation as part of impact to the
+ commissioning activities.
+ Performs commissioning testing, vendor installation, vendor operational qualification (I/OQ) of systems arising from
+ projects.
+ Draft / oversight of commissioning protocol, execute and write commissioning reports for GxP (direct impact system)
+ and non-GxP (not direct impact system).
+ Work with vendors and project engineering to ensure systems are ready for installation, and start-up testing. Work with
+ support department such as Digital Plant, Facilities, Metrology and Maintenance to ensure systems are installed
+ adequately and ready for qualification (for GxP direct impact system) or released to system owners for system use (for
+ non-GxP systems).
+ Support multiple projects while serving as a point of contact for capital execution projects. Partner with project
+ managers to determine project priorities, track progress toward project milestones and deliverables, and provide regular project status updates to site management.
+ Works collaboratively with Engineering, Digital Plant, Manufacturing and Quality.
+ Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and
+ increase efficiencies.
+ Ensure alignment with BMS directives and industry guidelines on commissioning.
+ Performs other duties as assigned.
Knowledge & Skill:
+ You should have the ability to execute smaller, but complex technical projects. You must have demonstrated
+ effectiveness working in both a team environment as well as an individual contributor role.
+ Direct experience with equipment, facility, sterilization commissioning and qualification, critical utilities validation, and temperature mapping concepts is preferred.
+ A working understanding of lean principles is preferred. Excellent project management, communication, and technical writing skills are required.
+ Demonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams and Standard Operating Procedures
Qualifications:
+ A minimum of 1+ years relevant experience with process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in an FDA regulated manufacturing facility.
+ Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, related discipline, or its equivalent is required.
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: R1587635
Updated: 2024-12-26 03:26:58.324 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 .
The Commissioning Engineer I will be part of the Commissioning team reporting to Sr. Manager, Commissioning Engineering and support clinical and commercial Devens manufacturing facility. This position may lead contractors for complete asset life cycle onboarding oversight of commissioning and any other effort arising from design and implementation of new/modified asset(s) as part of capital projects at the Devens site. The incumbent will apply existing and new knowledge of Engineering Project Management to support multiple, high-pace projects across multiple functions as part of the commissioning phase of asset introduction and/or modifications. This position will lead, execute and assist in commissioning activities for capital projects and collaboratively develop our commissioning protocols and practices. This position is responsible for facilities, utilities, equipment and analytical instruments commissioning project activities in both GxP and non-GxP systems. This position will interface with key stakeholder groups such as, Engineering, Capital Project Management, Quality Assurance, Quality Control, Qualification, Manufacturing Engineering, Facilities operations/maintenance, Validation and Manufacturing.
Key Responsibilities:
+ Executes and/or Leads installation, commissioning activities of area specific process equipment, validation of SIP/CIP
+ processes, qualification of environmental chambers and qualification of critical and non-critical process utility systems.
+ Provides Single Point of Contact (SPOC) on all commissioning activities for a specific manufacturing area (Production
+ Support, Cell Culture, Purification, and Critical Utilities), working with designated peers to create a team/triage
+ environment.
+ Assignment of SPOC to designated manufacturing area is based on demonstrated technical knowledge and experience
+ with associated equipment/systems.
+ Lead and execute vendor qualification protocols and triage commissioning deviation as part of impact to the
+ commissioning activities.
+ Performs commissioning testing, vendor installation, vendor operational qualification (I/OQ) of systems arising from
+ projects.
+ Draft / oversight of commissioning protocol, execute and write commissioning reports for GxP (direct impact system)
+ and non-GxP (not direct impact system).
+ Work with vendors and project engineering to ensure systems are ready for installation, and start-up testing. Work with
+ support department such as Digital Plant, Facilities, Metrology and Maintenance to ensure systems are installed
+ adequately and ready for qualification (for GxP direct impact system) or released to system owners for system use (for
+ non-GxP systems).
+ Support multiple projects while serving as a point of contact for capital execution projects. Partner with project
+ managers to determine project priorities, track progress toward project milestones and deliverables, and provide regular project status updates to site management.
+ Works collaboratively with Engineering, Digital Plant, Manufacturing and Quality.
+ Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and
+ increase efficiencies.
+ Ensure alignment with BMS directives and industry guidelines on commissioning.
+ Performs other duties as assigned.
Knowledge & Skill:
+ You should have the ability to execute smaller, but complex technical projects. You must have demonstrated
+ effectiveness working in both a team environment as well as an individual contributor role.
+ Direct experience with equipment, facility, sterilization commissioning and qualification, critical utilities validation, and temperature mapping concepts is preferred.
+ A working understanding of lean principles is preferred. Excellent project management, communication, and technical writing skills are required.
+ Demonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams and Standard Operating Procedures
Qualifications:
+ A minimum of 1+ years relevant experience with process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in an FDA regulated manufacturing facility.
+ Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, related discipline, or its equivalent is required.
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: R1587635
Updated: 2024-12-26 03:26:58.324 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