Job Description

Target PR Range: 20-30/hr
*Depending on experiencf

Position Summary:
Operating a state-of-the-art immunotherapy manufacturing facility with advanced system
automation and data integration to enable the production and delivery of our cell therapy to cancer patients.  We are looking for a forward-thinking MES junior analyst to join our GMP Systems and Data Management team. The MES junior analyst will be responsible for supporting the manufacturing execution system (MES) and electronic Master Batch Records (MBRs).

This role will also provide MES system support to Manufacturing, MSAT, Technical Transfer, Quality and Supply Chain to ensure priorities are being addressed in a timely manner to meet clinical programs timeline.

Key Responsibilities:
Support the system owner as needed in the design, development, and qualification of 
manufacturing execution systems.
Collaborate with cross-functional teams to outline process requirements, develop manufacturing batch records, recipes, and workflows, ensuring that operational data, configurations, processes and reports meet all regulatory requirements.
Configure and maintain system masterdata for new and existing clinical program
Support the roll-out of MES software by updating relevant documentation, end user training, and managing user accounts.
Provide MES support for production that includes hours outside of normal business hours (weekends, holidays, nights and on call).
Willingness to learn GxP systems in addition to MES, such as Laboratory Information 
Management Systems.

Minimum Requirements:
Bachelor’s Degree or higher in engineering fields (preferred chemical or electrical) or computer science.

Requirements:
Working in a fast paced, and sometimes ambiguous environment
Excellent communication, and technical writing
Proven critical thinker with strong logical and analytical skills
Team-oriented

Job Tags

Holiday work, Contract work, Night shift,

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