Validation Engineer

We are seeking an experienced CQV (Commissioning, Qualification, and Validation) Engineer with over 5 years in the pharmaceutical and cGMP industry.

Key Responsibilities:

• Lead and participate in Engineering, Procurement, Construction, Validation for GMP facilities.
• Prepare, execute, and review IQ, OQ, PQ validation protocols for equipment, facilities, and utilities.
• Conduct root cause analysis and lead quality investigations (deviations, CAPA, change control).
• Manage validation schedules and resource alignment.
• Support manufacturing process setup and technical activities.
• Perform FAT/SAT activities and temperature mapping.
• Utilize Delta V, Kneat, Veeva, and Trackwise.

Requirements:

• 5+ years CQV experience in pharma/cGMP.
• Strong understanding of cGMP, USP, EMA, ICH, 21 CFR, GAMP5, ISPE, PDA, ASME BPE.
• Proven problem-solving and project coordination skills.
• Excellent communication abilities.
• Bachelor of Science in Chemical/Biological Engineering or related field.