Validation Engineer

ANTER RECRUITMENT PTE. LTD.; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading recruitment firm in Singapore is seeking an experienced CQV (Commissioning, Qualification, and Validation) Engineer with over 8 years in the pharmaceutical and cGMP industry. The ideal candidate will lead engineering projects, conduct quality investigations, and prepare validation protocols. Strong understanding of cGMP regulations and excellent communication skills are essential. This role offers an opportunity to work in a dynamic environment focused on GMP facilities.

Qualifications

• 8+ years of experience in CQV in pharma/cGMP.
• Strong understanding of cGMP, USP, EMA ICH, 21 CFR, GAMP5, ISPE, PDA, ASME BPE.
• Proven problem-solving and project coordination skills.

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

CQV experience

Problem-solving skills

Project coordination skills

Communication abilities

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.