CQV Engineer: Validation & Compliance Lead

ENVIRODYNAMICS SOLUTIONS PTE. LTD.; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

EnviroDynamics Solutions Pte Ltd in Singapore seeks a senior validator to lead full-lifecycle qualification of analytical instruments and bioprocess equipment. You will draft protocols, risk assessments, URS/FS, and qualification reports, while coordinating with vendors and cross-functional teams.

Strong GMP knowledge and problem-solving are essential. The role requires 5–15 years in validation, deep understanding of regulatory standards, and hands-on experience with instruments and bioprocess

Qualifications

• 5–15 years in validation, quality systems, operations or related fields.
• Experience in multiple GMP validation disciplines with advanced technical knowledge.
• Knowledge of Validation Lifecycle: URS/FS/FAT/SAT/IQ/OQ/PQ protocols and regulatory standards.
• Experience with Documentum or Maximo; TrackWise a plus.
• Strong written and verbal communication; excellent organizational skills.

Responsibilities

• Execute full-lifecycle qualification for analytical instruments (HPLC/UPLC, GC, MS, UV-Vis, FTIR, etc.).
• Draft and execute validation protocols, risk assessments (FMEA), URS, FS and qualification summaries.
• Manage vendor qualification activities and review third-party documentation.
• Develop risk assessments, validation plans, and reports supporting system qualification.
• Support qualification for bioprocess equipment (bioreactors, AKTA systems, TFF, incubators).
• Investigate deviations and write investigation and summary reports.
• Promote cGMP and regulatory compliance; apply good judgment in methods.
• Hands-on experience with biopharma process equipment is preferred.

Skills

Attention to detail

Strong communication

Independent worker

Time management

Judgment in methods

Education

Biotechnology

Mechanical Engineering

Chemical Engineering

Tools

Documentum

Maximo

TrackWise

Job description

EnviroDynamics Solutions Pte Ltd in Singapore seeks a senior validator to lead full-lifecycle qualification of analytical instruments and bioprocess equipment. You will draft protocols, risk assessments, URS/FS, and qualification reports, while coordinating with vendors and cross-functional teams.

Strong GMP knowledge and problem-solving are essential. The role requires 5–15 years in validation, deep understanding of regulatory standards, and hands-on experience with instruments and bioprocess