Manufacturing System Administrator (Contractor)

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.

The Manufacturing System Administrator (Contractor) is responsible for supporting the daily on-site operations of GMP Technical Operations, including, but not limited to, manufacturing, quality assurance, quality control, supply chain, patient experience, facilities/engineering, and technical development. The administrator reports to the senior IT Manager of GMP Systems.

Requirements

• The systems in scope include LIMS, MES, Electronic Batch Record, Laboratory Systems, BMS, BMRAM, GMP Labeling, Barcoding, Shop-Floor Systems, and data management and analytics.
• Provide all needed technical support to implement LIMS solutions, development and integration of LIMS with laboratory instruments and other enterprise systems.
• Collaborate with laboratory personnel and IT teams to gather requirements and translate them into LIMS configurations and workflows.
• Perform system upgrades, patches, and maintenance for GMP systems, ensuring system stability and performance.
• Provide technical support and guidance to ensure best practices in LIMS, MES, Electronic Batch Record, Laboratory Systems, BMS, BMRAM, GMP Labeling, Barcoding, Shop-Floor Systems, and data management and analytics.
• Troubleshoot and resolve any issues related to the GMP systems, working closely with end-users and support teams.
• Conduct system testing, validation, and documentation to ensure compliance with regulatory and industry standards.
• The position requires a broad understanding of GMP regulatory frameworks and obligations. The position requires enthusiasm, passion, attention to detail and a desire to create new medicines for patients.
• The position will perform the role of system administrator for site GMP systems. The responsibility will include support user account creation and system life cycle management.
• Resolve issues related to GMP Systems, identifying root causes of problems, and providing technical support to users or other teams within the organization.
• Ensuring that IT processes and procedures are well documented and followed for compliance.

Education/Experience

• Bachelor’s degree in computer science or related discipline or equivalent experience.
• 5-10 years of implementing and supporting IT within manufacturing/supply chain in biotechnology or life sciences companies.
• Strong Working Experience in developing and driving Computer System Validation program initiatives including GxP systems and ensuring CFR part 11 compliance.
• Experience leveraging digital systems to drive business workflows and processes in quality-manufacturing production environments.

• Experience with shop floor automation, ERP, MES, Quality, Laboratory, Warehouse, Engineering/Facilities, Supply Chain, and Chain of Custody/Chain of Identity,
• Experience with implementing and automating the warehouse.
• Experience with Manufacturing Execution System/ Electronic Batch Record
• Experience with commissioning and validation of shop-floor equipment and devices
• Experience in articulating strategy and vision for Industry 4.0, and the Internet of Things
• Previous experience working in GMP Environment is required.
• Strong project and portfolio management skills. Ability to oversee multiple projects, activities, and tasks simultaneously.
• Ability to solve problems using a structured methodology
• Skilled in using continuous improvement frameworks (Kaizen, LEAN, Six Sigma)
• Skilled with business process improvements and design
• Strong technology background in manufacturing and supply chain across BioPharma/Cell Therapy Industry
• Experience with Data and analytics platforms, including ability to use AI/ML

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.