Validation of pharmaceutical processes and equipment
Knowledge of 21cfr 211, 820 and part 11
The Sr. CQV Engineer will lead efforts and execute commissioning and qualification programs to ensure equipment, facilities, and utilities meet compliance and fitness standards
Job Summary
The Sr. CQV Engineer will lead efforts and execute commissioning and qualification programs to ensure equipment, facilities, and utilities meet compliance and fitness standards.
This role involves managing documentation, coordinating C&Q deliverables, and maintaining qualified states in alignment with company policies.
The engineer will also assist in continuous improvement initiatives and present results to regulatory agencies as part of the site’s validation objectives.
Matching Summary
The Sr. CQV Engineer will lead efforts and execute commissioning and qualification programs to ensure equipment, facilities, and utilities meet compliance and fitness standards.
Skills & Requirements
Must-have
Commissioning and qualification documentation
Validation of pharmaceutical processes and equipment
Knowledge of 21CFR 211, 820 and part 11
Experience with GMP compliance
Cross-functional communication skills
Project management for C&Q deliverables
Nice-to-have
Team player with limited supervision
Presentation skills for regulatory agencies
Flexibility to work off-shifts and weekends
Continuous improvement of validation programs
Troubleshooting deviations and failures
Key Requirements
Bachelor’s degree in science with 5+ years experience or Master’s degree with 3+ years
Knowledge of 21CFR 211, 820 and part 11 regulations
Familiarity with ISO standards and ISPE Guidelines
Experience with inhalation, sterile products and medical devices
Ability to work independently and in teams
Excellent oral presentation and communication skills