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CQV Engineer

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About the Role

We are seeking experienced and detail-oriented CQV Engineers to join our growing team. In this role, you will be instrumental in ensuring that all manufacturing equipment and utilities are rigorously commissioned and qualified. Your primary objective is to guarantee that our facilities meet the highest standards of safety and compliance prior to operational use in manufacturing.

This is a high-impact role requiring a blend of technical strategy and hands-on execution within a regulated environment.

Key Responsibilities

  • Strategy Development: Formulate comprehensive CQV strategies and detailed execution plans tailored to specific manufacturing equipment and utility systems.
  • Phase Coordination: Lead and coordinate the execution of all project phases, including Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Readiness Verification: Rigorously verify equipment readiness and system integrity prior to handover to the production team.
  • Cross-Functional Collaboration: Work closely with Engineering, Maintenance, and Quality Assurance teams to ensure alignment with project timelines and regulatory standards.
  • Compliance: Ensure all activities adhere to site-specific SOPs and global regulatory requirements.
Key Deliverables As a CQV Engineer, you will be responsible for the generation and approval of:
  • Detailed Commissioning Reports.
  • IQ/OQ/PQ Protocols and Final Reports.
  • Complete Equipment Turnover Packages (ETOPs).
  • CQV Traceability Matrices to ensure all requirements are met and verified.
Required Skills & Qualifications
  • Education: Bachelor’s Degree in Engineering (Mechanical, Chemical, Electrical) or a related Scientific field.
  • Experience: Proven hands-on experience with equipment commissioning, testing, and validation within a regulated industry (e.g., Pharmaceutical, Biotech, or Medical Devices).
  • Technical Knowledge: Strong understanding of ASTM E2500 standards for specification, design, and verification.
  • Documentation: High proficiency in Good Documentation Practices (GDP) and technical writing.
  • Problem Solving: Strong analytical skills with the ability to troubleshoot equipment failures during the qualification phase.
Work Location: In person, location in Singapore Pay: RM19,500.00 - RM27,000.00 per month

Work Location: In person

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