Jobs at Scientific Protein Laboratories

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.

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.

Develops, administers, and maintains manufacturing training programs to ensure cGMP and regulatory compliance. Manages LMS and training records, coordinates onboarding and refresher training, develops SOP-based curriculum with SMEs, tracks qualifications and compliance metrics, supports audits, and drives continuous improvement of training processes.

Ensure cGMP-compliant manufacturing through deviation investigations, CAPA management, authoring and maintaining SOPs and batch records, supporting audits and validations, performing root-cause analysis (5 Whys, FMEA), driving continuous improvement, and collaborating with QA, QC, Engineering, and Supply Chain to maintain product quality and regulatory compliance.

Manage engineering projects for cGMP API manufacturing from scope, design, budgeting, and construction through equipment installation, commissioning, validation, and documentation. Lead process and utility optimization (WFI/RO, clean steam, HVAC), DOE/SPC-driven improvements, reliability/CMMS programs, cross-functional troubleshooting (5-Why, FMEA, DMAIC), contractor management, and institutionalize changes via change control, SOPs, and IQ/OQ/PQ to ensure compliance and operational efficiency.

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.

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.

Perform skilled repair, maintenance, troubleshooting, calibration, and preventive maintenance on production and utility equipment (instrumentation/controls, HVAC/refrigeration, mechanical systems). Support plant systems including solvent recovery, peptone concentration, boilers, PW/WFI, freeze dryers and fire/security systems. Execute electrical and pipefitting repairs and perform system tests and analyses under minimal supervision.

Calibrate and maintain a wide range of production, research, and QC instruments to ensure cGMP compliance. Write calibration SOPs and technical reports, maintain calibration records and CMIS, develop calibration procedures, train junior staff, and oversee third-party calibration contractors.

Lead manufacturing compliance and training to ensure cGMP adherence and inspection readiness. Oversee training programs, evaluate effectiveness, support investigations and CAPAs, coach production staff, and collaborate with QA, QC, engineering, and supply chain to drive procedural discipline and continuous improvement across manufacturing operations.

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.

Manage on-site QA operations for cGMP API manufacturing: supervise QA teams, lead investigations and CAPA, perform batch record review and product release, support audits/inspections, and drive quality system continuous improvement and cross-functional compliance.

Supervise and mentor a metrology/calibration team, maintain cGMP-compliant metrology systems, perform calibrations and OOT assessments, manage CMIS records, support audits, and develop calibration procedures.