This role leads validation activities across facilities, utilities, equipment, computerized systems, and processes to ensure ongoing compliance with FDA, EU GMP, ICH, and global regulatory standards. The ideal candidate brings deep expertise in aseptic processing, cleanroom environments, and contamination control strategies.
Qualifications:
• Bachelor’s degree in Engineering or related Life Sciences field
• 7+ years of hands-on validation experience in sterile injectable or biopharmaceutical manufacturing
• Strong technical writing and documentation skills
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