CQV Engineer

• Write and execute validation protocols for new and existing equipment, facility utilities, and manufacturing processes
• Start-up C&Q experience of process and utility systems
• Work as part of a large project team and be a system owner for a system
• Author and execute CQV documentation for a defined system against project schedule and timelines
• Deviation/Nonconformance write up and close out resolution
• Provide direction, input, review and approval of engineering studies, FAT, IQ, OQ, and PQ validation protocols and reports for facilities, equipment, systems, and utilities

• 3+ years professional experience in a biologics/pharmaceutical
• Experience developing and executing process, equipment, and validation protocols
• Knowledge of cGMP practices and standards
• Excellent written and verbal communication and interpersonal skills
• Bachelor’s degree (preferably in an engineering discipline) or relevant scientific or related discipline

Prefer an individual with a positive, results oriented, team mindset, and capable of changing direction and focus as priorities shift