EFU Validation Engineer

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).
• Strong knowledge of GMP/cGMP standards.
• Ability to author/review SOPs and validation protocols.
• Good communication skills for cross-functional collaboration.