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MES System Administrator (Contractor)
Winston-Salem, North Carolina, United States
Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.
MES System Consultant/Administrator
Role/Responsibilities:
- Experienced with design, implementation, and support of Manufacturing Execution System (MES) and/or Electronic Batch Records (EBRs)
- Providing day-to-day expertise to manufacturing operations for use of EBRs
- Managing vendors to troubleshoot system issues and functionality
- Escalate and ensure closure of all production issues related to EBRs/MES
- Lead deployment of system patches and upgrades as necessary
- Partner with business for continuous improvement
- Experience with building integrations between MES and other systems.
- Implement best practices about adoption of EBRs through site operations
- Manage vendor SLA and ensure closure of all issues
- Partner with stakeholders to ensure system stays in compliance with company and industry regulations including validated state
- Partner with stakeholders to create and manage system change controls and associate validation activities
- Partner with vendor and stakeholders to plan enhancements including leveraging new functionality
Location:
- Onsite/Hybrid at Winston Salem, NC (3-5 days/week)
Experience:
- Previous experience (5 years plus) with implementation and support of MES/EBRs
- Pharma/Biotech/Cell Therapy Experience Required
- FDA GMP experience is required
- Experience with IT Systems Lifecycle
- Computer Systems Validation Experience
- Previous Knowledge of MasterControl
- Experience with other leading industry MES Systems is a Plus
ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.
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