Teams at Scientific Protein Laboratories

Develops, maintains, and troubleshoots Rockwell PLC, HMI, and PlantPAx systems in a cGMP pharmaceutical manufacturing environment. The role programs batch-control systems, supports validation and capital projects, documents changes, resolves automation issues, and ensures compliance with ISA-88, FDA 21 CFR Part 11, data integrity, and quality requirements. It also collaborates with production, quality, engineering, vendors, and maintenance teams on system improvements, commissioning, and network infrastructure.

Perform calibration, maintenance, troubleshooting, minor repairs, and documentation for measurement and laboratory equipment in a regulated pharmaceutical manufacturing environment. Maintain traceable standards and calibration records in CMMS/CMIS, coordinate calibration services, support audits and corrective actions, and ensure compliance with cGMP, FDA requirements, and company procedures. Collaborate with Quality, Manufacturing, Engineering, and Facilities while supporting equipment qualification and continuous improvement.

Manages pharmaceutical quality systems and cGMP compliance, including training, deviations, investigations, CAPAs, change controls, validation documents, product release, quality agreements, and audit responses. Administers the electronic quality management system, tracks quality metrics, supports continuous improvement, and oversees customer complaints and communications. Leads personnel workload management, training coordination, and external agency and customer audits.