1. PURPOSE AND SCOPE OF POSITION:Process Engineers provide 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. Process Engineers work 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 include participation in process tech transfer, supports incoming process changes by communicating the changes to applicable departments, and participates in process improvement projects at the site. Process engineers work to identify and drive continuous improvements to the manufacturing process.
2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities• Senior Specialist, Associate Process Engineer II: Minimum 2.5+ years of industry experience with a minimum of 1 year of relevant experience in GMP biologic/cell therapy manufacturing technical or process support. cGMP and/or Cell Therapy manufacturing experience preferred.
3. DUTIES AND RESPONSIBILITIES• Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing
• Facilitates deviation prevention and deviation closure through site quality systems
• Analyze and summarize manufacturing data to support impact assessments and investigations
• Owner of change controls for routine process and procedure changes
• CAPA owner for Manufacturing improvements
• Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records
• Participates in technology transfer efforts for new processes and product implementation
• Train and support GMP operators on new procedures, processes, and changes
• Applies continuous improvement tools to identify and close procedural and compliance gaps
• Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts.
• Interfaces with other functions such as Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering
• Support 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.
4. EDUCATION AND EXPERIENCE• BSc and/or MSc degree in Science or Chem/Bio Engineering
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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Compensation Overview:Devens - MA - US: $87,660 - $106,224
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employees work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
