Validation Engineer

ANTER RECRUITMENT PTE. LTD.; Town of Islip (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading recruitment firm is seeking a CQV Engineer with over 8 years of experience in the pharmaceutical and cGMP industry. The successful candidate will lead validation processes, manage schedules, and support technical activities at GMP facilities. Candidates must possess a Bachelor's degree in Chemical or Biological Engineering and have a strong understanding of regulatory standards.

Qualifications

• 8+ years CQV experience in pharma/cGMP.
• Strong understanding of cGMP, USP, EMA, ICH, 21 CFR, GAMP5, ISPE, PDA, ASME BPE.

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.

Skills

Problem-solving

Project coordination

Communication

Education

Bachelor of Science in Chemical/Biological Engineering

Tools

Delta V

Kneat

Veeva

Trackwise

Job description

We are seeking an experienced CQV (Commissioning, Qualification, and Validation) Engineer with over 8 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:

• 8+ 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.