Process Engineer I
Bristol Myers Squibb
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. 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 . Cell Therapy Technical Operations (CTTO) is seeking a highly motivated Process Engineer I to provide technical leadership for gene delivery and editing products. This role will be responsible for supporting process and technology transfers, leading commercialization activities, and providing end-to-end technical process support across the product lifecycle. The successful candidate will serve as a technical Subject Matter Expert (SME), partnering with internal and external stakeholders to ensure robust, compliant, and scalable viral vector processes. The position includes accountability for providing technical oversight of GMP manufacturing campaigns with CDMOs, reviewing and approving GMP documentation, and analyzing/presenting manufacturing data to support decision-making. This individual will serve as the lead investigator for deviations , own associated change controls , and contribute to regulatory filings. In addition, the role will support cross-functional teams in defining and implementing process control strategies, represent CTTO on internal strategy teams, and drive business-critical initiatives that enable product advancement and supply reliability. Travel of approximately 10-20% is expected. Key Responsibilities:
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 a supportive culture, promoting global participation 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 an 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 [email protected] . 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. 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: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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. 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 . Cell Therapy Technical Operations (CTTO) is seeking a highly motivated Process Engineer I to provide technical leadership for gene delivery and editing products. This role will be responsible for supporting process and technology transfers, leading commercialization activities, and providing end-to-end technical process support across the product lifecycle. The successful candidate will serve as a technical Subject Matter Expert (SME), partnering with internal and external stakeholders to ensure robust, compliant, and scalable viral vector processes. The position includes accountability for providing technical oversight of GMP manufacturing campaigns with CDMOs, reviewing and approving GMP documentation, and analyzing/presenting manufacturing data to support decision-making. This individual will serve as the lead investigator for deviations , own associated change controls , and contribute to regulatory filings. In addition, the role will support cross-functional teams in defining and implementing process control strategies, represent CTTO on internal strategy teams, and drive business-critical initiatives that enable product advancement and supply reliability. Travel of approximately 10-20% is expected. Key Responsibilities:
- Support process and technology transfers, change management, and technical process support for gene delivery and editing products.
- Serve as a technical Subject Matter Expert (SME) within CTTO and across cross-functional project teams.
- Author regulatory filing sections throughout the product lifecycle.
- Assess process capability and lead investigations through analysis of manufacturing process data.
- Own and lead deviation investigations and associated change controls.
- Provide technical oversight during technology transfer and GMP manufacturing campaigns with Contract Development and Manufacturing Organizations (CDMOs).
- Review and approve GMP manufacturing documentation as required.
- Analyze and present manufacturing data to internal and external stakeholders to drive decision-making.
- Lead cross-functional teams in defining and implementing process control strategies.
- Support the commercialization and lifecycle management of viral vector products.
- Represent CTTO as the technical lead on internal strategy and governance teams.
- Willingness to travel 10-20%.
- B.S. or M.S. in Chemical Engineering, Bioengineering, Biotechnology, or related field with 4-8 years of relevant experience in process development or commercial manufacturing, or Ph.D. with a minimum of 2 years of relevant experience.
- Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and manage multiple projects.
- Experience with leading deviation investigations and owning change controls
- Experience providing technical support in clinical or commercial GMP environments.
- Strong knowledge of cGMP, ICH guidelines, PPQ (process validation), and control strategy development.
- Experience authoring, reviewing, and approving GMP documentation.
- Familiarity with disposable technologies such as single-use bioreactors (SUBs) and mixers (SUMs).
- Experience with data analysis tools (e.g., R, SAS) and root-cause analysis methodologies.
- Experience with process control strategies and Six Sigma principles a plus.
- Strong communication and presentation skills, with the ability to clearly explain complex technical concepts to cross-functional stakeholders.
- Knowledge of cellular immunology and/or vector manufacturing preferred.
- Knowledge of lentiviral or adeno-associated virus (AAV) manufacturing is a plus.
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 a supportive culture, promoting global participation 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 an 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 [email protected] . 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. 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: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 2025-09-26
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