Core Responsibilities
Execute commissioning and qualification deliverables for facilities and utilities. Author, review, and approve pre- and post-execution validation documents. Ensure adherence to GMP, GXP, and company validation standards. Maintain validated state of equipment, utilities, and facilities. Support CAPA (Corrective and Preventive Actions) investigations for validation failures. Participate in internal/external audits and regulatory inspections. Provide documentation and technical support to sustain compliance. Work with engineering teams on new installations to ensure commissioning documentation meets cGMP requirements. May supervise contract validation resources to ensure timely completion of tasks.
Qualifications Education:
Bachelor's degree in engineering, Chemistry, Biology, or related life sciences. At least
3 years of CSV/validation experience
preferred. Prior exposure to
facilities/utilities systems
(e.g., HVAC, water systems, cleanrooms). S...