Teams at cGMP Consulting

Manage and design electronic batch records in PAS-X for pharmaceutical manufacturing. Responsibilities include EBR template development, SOP maintenance, system integration with SAP and document management systems, equipment-data automation, testing, troubleshooting, validation, change control, deviation investigations, KPI monitoring, and cross-functional coordination. The role requires expertise in cGMP, FDA regulations, 21 CFR Part 11, data integrity, pharmaceutical manufacturing, databases, and virtual machines.

Manage multiple GMP engineering and compliance projects from planning through closeout. Responsibilities include developing timelines and budgets, coordinating cross-functional teams and clients, managing risks and scope changes, reviewing GMP deliverables, maintaining project records, forecasting finances, and supporting regulatory alignment. The role requires leadership in a pharmaceutical manufacturing environment, familiarity with FDA requirements, and strong stakeholder-management skills.

Lead and manage pharmaceutical automation and validation projects using DeltaV. Develop schedules, allocate resources, manage risks, ensure cGMP/FDA compliance, communicate with clients, and support project forecasting and documentation using Word, Excel, and document management tools.