Specialist, Associate Process Engineer - Devens MA

Overview

ATTENTION MILITARY AFFILIATED JOB SEEKERS — Our organization works with partner companies to source qualified talent for open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please submit your application. Unless specifically stated otherwise, this role is On-Site at the location detailed in the job post.

At Bristol Myers Squibb we are reimagining the future of cell therapy and are seeking individuals to challenge themselves and contribute to our Cell Therapy team.

The Specialist, Associate Process Engineer, Cell Therapy provides technical support to the Devens Cell Therapy Facility (CTF) Manufacturing processes in a GMP environment. The role involves troubleshooting process and equipment-related issues during manufacturing, working with Manufacturing and Quality to determine immediate corrective actions for deviations, identifying root causes, and implementing long-term preventive actions. Responsibilities include participation in process tech transfer, supporting incoming process changes by communicating them to applicable departments, and participating in site process improvement projects to drive continuous manufacturing improvements.

TBD

• Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing
• Facilitates deviation prevention and deviation closure through site quality systems
• Analyzes and summarizes 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
• Trains and supports GMP operators on new procedures, processes, and changes
• Applies continuous improvement tools to identify and close procedural and compliance gaps
• Identifies opportunities for process improvements and operational efficiencies, and leads implementation efforts
• Interfaces with Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering
• Supports equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements, and participating in impact assessments
• Ability to perform gowning activities and enter the manufacturing plant; exposure to strong magnetic fields is commonplace in the manufacturing areas

• BSc and/or MSc degree in Science or Chemical/Biological Engineering
• Minimum 0-3 years of industry experience; cGMP and/or Cell Therapy manufacturing experience preferred

This job description describes the general nature and level of work being performed. Primary duties are intended to describe essential functions. Other duties may be assigned as needed by management.

Location:

Devens, MA, US

Salary Range: $75,000–$100,000; reported range: $79,150–$95,914

Employer:

Bristol Myers Squibb (BMS)