Jobs 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.

Develop, scale up, optimize, and transfer biopharmaceutical manufacturing processes from lab/pilot to commercial GMP production. Prepare PFDs, mass balances, protocols, SOPs, and validation activities (IQ/OQ/PQ). Support troubleshooting, CAPAs, equipment selection, technical reporting, training, and cross-functional project work while ensuring cGMP and regulatory compliance.

Supervise on-site Quality Assurance activities for cGMP API manufacturing, including inspections, batch record review, raw material release, investigations, deviations, change controls, CAPAs, product release decisions, audit support, and QA metrics reporting. Manage QA staff, training, procedures, and continuous improvement to maintain compliance with FDA/ICH/USDA/ISPE standards.

Execute and maintain quality systems for a cGMP biopharmaceutical site, including GMP training, review/approval of validation and qualification documents, managing investigations/deviations/CAPAs, change control, audit coordination/response, APR preparation, and continuous improvement projects.

Supervise daily cGMP manufacturing operations for pancreatin production, ensuring safe, compliant, and timely execution of batches. Oversee personnel, review batch records, enforce documentation integrity (ALCOA+), coordinate with Quality/Maintenance, lead shift activities, support investigations, and drive continuous improvement.

Administer, configure, validate, and support the electronic Quality Management System (eQMS) and Electronic Batch Records (EBRs). Manage integrations, ensure data integrity and regulatory compliance (21 CFR Part 11, EU Annex 11, ALCOA+), develop reports/metrics, provide user support/training, execute CSV activities, and support audits and remediation in a cGMP biopharma environment.

Develop, maintain, and troubleshoot Rockwell PLC and FactoryTalk HMI/PlantPAx systems in a cGMP pharmaceutical environment. Ensure compliance with FDA 21 CFR Part 11 and ISA-88, produce revision-controlled documentation, support validation (IQ/OQ/PQ), collaborate with Production/Quality, and advise on automation for capital projects.

Lead pancreatin wet-processing manufacturing to meet production, quality, safety, and schedule targets under cGMP. Oversee frontline staff, batch execution, documentation, audits, deviations/CAPAs, continuous improvement, KPIs, budgets, and cross-functional collaboration.

Drive reliability improvements for cGMP pharmaceutical manufacturing equipment through failure analysis (RCA, FMEA), PM optimization, predictive maintenance (vibration, thermography, oil analysis, ultrasound), asset lifecycle support, supervision of engineering technicians, and leadership of reliability-driven capital and change-control projects to reduce unplanned downtime.

Lead design, implementation, and continuous improvement of company-level GxP and non-GxP training systems, curricula, and learning pathways. Coordinate training planning, maintain training records and systems, ensure regulatory compliance with Quality, monitor qualification status, analyze capability gaps tied to quality events, and drive training effectiveness and cross-functional alignment to support operational compliance in a regulated biopharmaceutical manufacturing environment.

Lead plant-floor reliability efforts including root-cause analysis, FMEA, PdM program development (vibration, thermography, oil analysis, ultrasound), PM program ownership, asset lifecycle support, and reliability-driven capital projects. Supervise Engineering Technicians, partner with Maintenance, Quality, Validation, and Engineering to reduce unplanned downtime, close CAPAs, manage change controls on GMP equipment, and analyze CMMS data to prioritize reliability improvements.