Cell Therapy Case Manager
Orca BioSalary not specified
Full Time
Mid-level (3 to 4 years), Senior (5 to 8 years)
Manager, Process Systems Engineer, Cell Therapy in Devens, MA at Bristol-Myers Squibb
Devens, Massachusetts, United States
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Cell Therapy, Biotechnology, PharmaceuticalsIndustries
Requirements
- Strong project management skills
- Expertise in manufacturing process and process systems (e.g., electronic batch records (MES), DeltaV, OSI Pi, process monitoring systems)
- Understanding of DeltaV and MES library objects
- Excellent coordination and collaboration skills with stakeholders (Manufacturing, Digital Plant, IT, Validation, Quality, MSAT)
- Leadership, enthusiasm, intellectual curiosity, scientific rigor
- Goal-oriented, flexible, and subject matter expert in process systems
Responsibilities
- Apply manufacturing process expertise and process system technical knowledge during change management
- Own User Requirements for process systems and ensure consistent execution of system modifications and changes, adhering to governing documents
- Work collaboratively with Manufacturing, Digital Plant, IT, Validation, Quality, and MSAT to drive change initiatives to closure and migrate to production
- Own the lifecycle of process system changes
- Gather user requirements for change development from site functional teams (manufacturing, engineering, warehouse, quality assurance)
- Use understanding of DeltaV and MES library objects to direct changes to associated systems
- Develop documentation to support qualification of DeltaV and MES recipes, including test scripts and User Requirements
- Execute testing of changes in the development environment to ensure functionality
- Support Chain of Identity program and ensure maintenance within process systems
- Manage User Acceptance Testing process for system qualification
- Develop and deliver reports from reporting software
- Use creative problem solving and provide technical expertise to management and less experienced professionals
- Provide technical support for manufacturing operations, investigations, and change controls as a process system subject matter expert
- Drive strong collaboration within the plant and across the network
- Build trust and effective relationships with peers and stakeholders
- Promote a mindset of continuous improvement, problem solving, and incident prevention
- Perform other tasks as assigned
Skills
MES
DeltaV
OSI Pi
electronic batch records
process monitoring systems
project management
Digital Plant
Manufacturing Operations
Bristol-Myers Squibb
Develops and delivers biopharmaceutical medicines
About Bristol-Myers Squibb
Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.
New York City, New YorkHeadquarters
1887Year Founded
$33,706.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees