Senior Manager, Equipment Commissioning & Qualification - Bristol Myers Squibb
Libertyville USG, IL
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 Senior Manager, Equipment Commissioning & Qualification supports the successful operation of laboratory and commercial manufacturing operations at a product site through interaction with internal team members and peer-level customers as well as external service providers. The incumbent in this role will support entry, junior, and experienced level professionals at the Libertyville Vector Manufacturing Facility (VMF), tasked with performing on demand, and qualification/requalification, periodic review activities of equipment according to established policies and procedures. In addition to answering questions and resolving issues for staff, the incumbent spends a portion of their time on individual work or improvements. The incumbent may lead modifications to work processes or procedures to functional management that impact their immediate function or organizational unit.
Key Responsibilities
Management Responsibilities:
+ Leading a team of up to 10 contract personnel.
+ Interview and hire internal and / or external personnel to fill necessary roles.
+ Provide direction to internal and external team members.
+ Ensure team members are appropriately trained for duties being performed.
+ Promote and ensure the safety of all team members and adherence to site EHS procedures and guidelines.
+ Ensure the team is in full compliance with local, site and global policies and procedures.
Operational Activities:
+ Delivers on Equipment Commissioning & Qualification activities, including scheduling, execution, and documentation of calibration, maintenance, repair, and equipment performance verification activities in both laboratory and manufacturing areas in Libertyville facilities.
+ Leads investigations into deviations, performance verification failures and develops and implements corrective and preventive actions (CAPAs) and supports associated activities per function as needed.
+ Initiate and own change controls, implements and supports associated activities per function as needed.
+ Develop, review and/or approve all qualification life cycle documents (e.g., SIA, Engineering Studies, Qualification Plan, URS, FS, DS, IOQ, PQ, and VSRs).
+ Ensures compliance with Validation Master Plans.
+ Coordinates and supervises vendors for preventative maintenance, calibration, and performance verification functions.
+ Develops and reviews written procedures for commissioning, qualification, and performance verification of equipment.
+ Maintain the equipment and instruments in a validated state.
+ Creates and maintains with the creation of departmental metrics. Understand and review departmental metrics.
Promotes and provides excellent customer service and support:
+ Regularly reviews, prioritizes, and promptly responds to customer equipment qualification/requalification, periodic review, and support requests.
+ Provides technical support and guidance on equipment qualification/requalification, periodic review, and validations issues. Interfaces with customers to ensure all expectations are being met.
+ Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
Inventory Management:
+ Work with Asset Cycle group to ensure system is updated as qualification/requalification, periodic review activities are performed.
Service Contract Support:
+ Manages Vendor service contracts to support equipment and systems including request for proposal development and manages bid process.
+ Provide feedback to departmental leadership on vendor performance and needs.
Regulatory Responsibilities:
+ Ensure Equipment Commissioning & Qualification program is maintained in compliance.
+ May be called upon to act as SME in both internal and regulatory audits.
Qualifications & Experience
+ BS in Engineering or Science related discipline preferred.
+ Minimum 10 years' experience in FDA-regulated industry
+ Minimum 7 years' experience working directly with manufacturing and laboratory equipment (e.g., CTUs & CRTs, upstream and downstream equipment, Filler Machine, analytical lab equipment, autoclave, AKTA, etc.) required.
+ Knowledge of cGMP in the pharmaceutical industry.
+ Knowledge using Document Control Management such as Infinity, ValGenesis, CMMS systems such as QAD, MAXIMO & SAP.
+ Strong knowledge using Ellab Valsuite Software and probe configuration.
+ Excellent computer skills including knowledge of calibration management and environmental monitoring systems.
+ Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
+ Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
+ 5 years of maintenance coordinating / planning experience, preferably in a laboratory environment.
+ Experience working in a commercial environment preferred
#BMSCART, #LI-Onsite, #Veteran
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/ 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.
Company: Bristol-Myers Squibb
Req Number: R1580261
Updated: 2024-05-31 03:53:59.991 UTC
Location: Libertyville USG-IL
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 Senior Manager, Equipment Commissioning & Qualification supports the successful operation of laboratory and commercial manufacturing operations at a product site through interaction with internal team members and peer-level customers as well as external service providers. The incumbent in this role will support entry, junior, and experienced level professionals at the Libertyville Vector Manufacturing Facility (VMF), tasked with performing on demand, and qualification/requalification, periodic review activities of equipment according to established policies and procedures. In addition to answering questions and resolving issues for staff, the incumbent spends a portion of their time on individual work or improvements. The incumbent may lead modifications to work processes or procedures to functional management that impact their immediate function or organizational unit.
Key Responsibilities
Management Responsibilities:
+ Leading a team of up to 10 contract personnel.
+ Interview and hire internal and / or external personnel to fill necessary roles.
+ Provide direction to internal and external team members.
+ Ensure team members are appropriately trained for duties being performed.
+ Promote and ensure the safety of all team members and adherence to site EHS procedures and guidelines.
+ Ensure the team is in full compliance with local, site and global policies and procedures.
Operational Activities:
+ Delivers on Equipment Commissioning & Qualification activities, including scheduling, execution, and documentation of calibration, maintenance, repair, and equipment performance verification activities in both laboratory and manufacturing areas in Libertyville facilities.
+ Leads investigations into deviations, performance verification failures and develops and implements corrective and preventive actions (CAPAs) and supports associated activities per function as needed.
+ Initiate and own change controls, implements and supports associated activities per function as needed.
+ Develop, review and/or approve all qualification life cycle documents (e.g., SIA, Engineering Studies, Qualification Plan, URS, FS, DS, IOQ, PQ, and VSRs).
+ Ensures compliance with Validation Master Plans.
+ Coordinates and supervises vendors for preventative maintenance, calibration, and performance verification functions.
+ Develops and reviews written procedures for commissioning, qualification, and performance verification of equipment.
+ Maintain the equipment and instruments in a validated state.
+ Creates and maintains with the creation of departmental metrics. Understand and review departmental metrics.
Promotes and provides excellent customer service and support:
+ Regularly reviews, prioritizes, and promptly responds to customer equipment qualification/requalification, periodic review, and support requests.
+ Provides technical support and guidance on equipment qualification/requalification, periodic review, and validations issues. Interfaces with customers to ensure all expectations are being met.
+ Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
Inventory Management:
+ Work with Asset Cycle group to ensure system is updated as qualification/requalification, periodic review activities are performed.
Service Contract Support:
+ Manages Vendor service contracts to support equipment and systems including request for proposal development and manages bid process.
+ Provide feedback to departmental leadership on vendor performance and needs.
Regulatory Responsibilities:
+ Ensure Equipment Commissioning & Qualification program is maintained in compliance.
+ May be called upon to act as SME in both internal and regulatory audits.
Qualifications & Experience
+ BS in Engineering or Science related discipline preferred.
+ Minimum 10 years' experience in FDA-regulated industry
+ Minimum 7 years' experience working directly with manufacturing and laboratory equipment (e.g., CTUs & CRTs, upstream and downstream equipment, Filler Machine, analytical lab equipment, autoclave, AKTA, etc.) required.
+ Knowledge of cGMP in the pharmaceutical industry.
+ Knowledge using Document Control Management such as Infinity, ValGenesis, CMMS systems such as QAD, MAXIMO & SAP.
+ Strong knowledge using Ellab Valsuite Software and probe configuration.
+ Excellent computer skills including knowledge of calibration management and environmental monitoring systems.
+ Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
+ Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
+ 5 years of maintenance coordinating / planning experience, preferably in a laboratory environment.
+ Experience working in a commercial environment preferred
#BMSCART, #LI-Onsite, #Veteran
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/ 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.
Company: Bristol-Myers Squibb
Req Number: R1580261
Updated: 2024-05-31 03:53:59.991 UTC
Location: Libertyville USG-IL
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