C&Q Engineer, Sr.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 6+ years of experience in commissioning, qualification, or validation within a GMP-regulated environment.
• Strong and proven knowledge of the complete equipment validation life cycle.
• Experience with Packaging Equipment, particularly Dividella Cartoner and ATS Assembly Systems.
• Deep understanding of GMP regulations, ISPE Baseline Guides, and ASTM E2500 principles.
• Ability to read and interpret P&IDs, electrical schematics, and system design documents.
• Experience with automation systems, process equipment, and utilities in pharmaceutical or biotechnology manufacturing.
• Excellent technical writing, analytical, and organizational skills.
• Strong communication and teamwork abilities.
• Ability to multi-task and work under pressure.
• Capable of understanding complex problems, collaborating across disciplines, and developing effective solutions.
• Proficiency in composing technical documents, outlines, and concise reports, as well as communicating technical information effectively.