Teams at Resilience (resilience.com).

Lead and execute validation activities for automated equipment and GxP computer systems (PLC/SCADA/DCS), authoring IQ/OQ/PQ, ensuring 21 CFR Part 11 and data integrity compliance. Serve as technical advisor, coach junior staff, manage validation lifecycle, resolve complex issues, support audits, and maintain validated state through change control and requalification in a cGMP biomanufacturing environment.

Owns and improves assigned biomanufacturing equipment processes, including process capability, validation, troubleshooting, change control, risk management, and technical documentation. Partners with Manufacturing, Quality, Maintenance, suppliers, and project teams to resolve issues, improve yield and efficiency, manage equipment lifecycle, support regulatory inspections, and deliver projects. Develops training for Operations, Engineering, and Maintenance personnel. The role requires work in a GMP or regulated manufacturing environment and occasional travel.

Provides executive and administrative support to C-suite leaders, including calendar management, travel logistics, correspondence, meeting materials, board meetings, conferences, off-sites, expenses, invoices, records, and special projects. Requires discretion, sound judgment, accuracy, independent execution, strong communication, and advanced Microsoft 365 skills. The role requires consistent in-person attendance and coordination with administrative colleagues.