Process Engineer, Clinical Supply Operations, Parenteral Manufacturing - Bristol Myers Squibb
New Brunswick, NJ
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 .
Our Clinical Supply Operations is responsible for the supply of drug product administered to patients in clinical studies worldwide. In Global Product Development and Supply the team works closely with our partners to deliver quality products safely, efficiently and on time while operationalizing the innovative technologies that will deliver the transformative medicines of tomorrow. As a member of our team, you will get the chance to play a pivotal role to positively impact patients' lives while developing professionally to achieve your own career goals.
Position Summary:
The Process Engineer is responsible for the execution and on-time final release of high-quality clinical products within the Parenteral Manufacturing Department to produce sterile injectable medicines for clinical trials. The individual will strive for 'right the first time' quality of operations and maintain a high level of awareness/compliance in an evolving Regulatory environment. This position will participate in matrix-based teams and/or act as department representative on assigned teams. As a proponent for change, the individual will explore areas for gains in efficiency and quality while appropriately balancing speed and risk.
Role & Responsibilities:
+ Interacts as appropriate to assure the success of a clinical program from initial planning stages through batch release
+ Creates and executes batch documentation in support of clinical parenteral manufacturing program
+ Tracks and assures all pre-requisites for batch manufacturing are released and available prior to execution
+ Assures that all required training is current
+ Closes investigations and CAPA's within specified time limits.
+ Efficiently prioritizes work and uses resources to meet designated timelines
+ Produces accurate and high-quality deliverables for assigned projects
+ Establishes and maintains a safe work environment for self and co-workers
+ Follows all relevant procedures, protocols, batch documents, etc.
+ Makes and acts on functional area task decisions while balancing speed, quality, and risk
+ Identifies and escalates technical and/or business issues promptly
+ Develops an understanding of cGMP's as they relate to evolving domestic and international Regulatory standards coupled with an awareness of new industry developments and trends
+ Builds strong relationships and collaborates effectively with peers within the functional area and broader organization
Qualifications and Experience:
+ Bachelor's degree in life sciences, engineering, or related discipline and 2+ years relevant experience or Associate's degree in life sciences, engineering, or related discipline and 4+ years relevant experience or Master's degree in life sciences, engineering, or related discipline and 0-2 years relevant experience
+ Aseptic technique and aseptic processing experience desirable
+ Demonstrated ability to manage projects in order to complete them in a timely fashion
+ Ability to communicate directly, openly, and honestly
+ Ability to establish effective plans to manage assigned workload and projects
+ Ability to participate in and enable high performing teams by removing communication barriers and energizing the team to achieve shared goals
+ Able to independently take on continuous improvement and operational excellence projects as time permits
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: R1585540
Updated: 2024-09-27 01:55:13.426 UTC
Location: New Brunswick-NJ
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 .
Our Clinical Supply Operations is responsible for the supply of drug product administered to patients in clinical studies worldwide. In Global Product Development and Supply the team works closely with our partners to deliver quality products safely, efficiently and on time while operationalizing the innovative technologies that will deliver the transformative medicines of tomorrow. As a member of our team, you will get the chance to play a pivotal role to positively impact patients' lives while developing professionally to achieve your own career goals.
Position Summary:
The Process Engineer is responsible for the execution and on-time final release of high-quality clinical products within the Parenteral Manufacturing Department to produce sterile injectable medicines for clinical trials. The individual will strive for 'right the first time' quality of operations and maintain a high level of awareness/compliance in an evolving Regulatory environment. This position will participate in matrix-based teams and/or act as department representative on assigned teams. As a proponent for change, the individual will explore areas for gains in efficiency and quality while appropriately balancing speed and risk.
Role & Responsibilities:
+ Interacts as appropriate to assure the success of a clinical program from initial planning stages through batch release
+ Creates and executes batch documentation in support of clinical parenteral manufacturing program
+ Tracks and assures all pre-requisites for batch manufacturing are released and available prior to execution
+ Assures that all required training is current
+ Closes investigations and CAPA's within specified time limits.
+ Efficiently prioritizes work and uses resources to meet designated timelines
+ Produces accurate and high-quality deliverables for assigned projects
+ Establishes and maintains a safe work environment for self and co-workers
+ Follows all relevant procedures, protocols, batch documents, etc.
+ Makes and acts on functional area task decisions while balancing speed, quality, and risk
+ Identifies and escalates technical and/or business issues promptly
+ Develops an understanding of cGMP's as they relate to evolving domestic and international Regulatory standards coupled with an awareness of new industry developments and trends
+ Builds strong relationships and collaborates effectively with peers within the functional area and broader organization
Qualifications and Experience:
+ Bachelor's degree in life sciences, engineering, or related discipline and 2+ years relevant experience or Associate's degree in life sciences, engineering, or related discipline and 4+ years relevant experience or Master's degree in life sciences, engineering, or related discipline and 0-2 years relevant experience
+ Aseptic technique and aseptic processing experience desirable
+ Demonstrated ability to manage projects in order to complete them in a timely fashion
+ Ability to communicate directly, openly, and honestly
+ Ability to establish effective plans to manage assigned workload and projects
+ Ability to participate in and enable high performing teams by removing communication barriers and energizing the team to achieve shared goals
+ Able to independently take on continuous improvement and operational excellence projects as time permits
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: R1585540
Updated: 2024-09-27 01:55:13.426 UTC
Location: New Brunswick-NJ
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