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Lead CQV Engineer (Pharma) (SG)

Date Posted: September 5, 2024

Job Description

We are seeking an experienced and highly skilled Lead CQV (Commissioning, Qualification, and Validation) Engineer to join our team for a significant pharmaceutical project in Singapore. The successful candidate will be responsible for ensuring that all systems and equipment are properly commissioned, qualified, and validated, in compliance with GMP regulations. This is a crucial role for the successful delivery of a complex, high-profile project.

Key Responsibilities

  • Lead the commissioning, qualification, and validation (CQV) activities for pharmaceutical manufacturing equipment, utilities, and systems.
  • Develop and execute qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, and systems.
  • Ensure all processes and systems are validated in compliance with GMP regulations and industry standards.
  • Maintain and prepare comprehensive documentation, including protocols, reports, and traceability matrices, for all CQV activities.
  • Collaborate closely with cross-functional teams including engineering, QA, and operations to ensure alignment and integration of CQV activities.
  • Identify and troubleshoot issues that arise during the commissioning, qualification, and validation processes, ensuring timely resolution.
  • Ensure all activities are aligned with industry standards, regulatory requirements, and company policies.
  • Provide regular status updates and reports to project stakeholders and management regarding CQV progress.
  • Stay up to date with the latest industry trends, regulations, and best practices in commissioning, qualification, and validation.

Required Qualifications and Skills

  • Bachelor’s degree in Engineering, Life Sciences, or a related field.
  • Minimum of 5 years of GMP experience in commissioning, qualification, and validation within the pharmaceutical industry.
  • Strong knowledge of pharmaceutical manufacturing processes, equipment, utilities, and systems.
  • Proven expertise in developing and executing IQ, OQ, and PQ protocols.
  • Excellent problem-solving and analytical skills with the ability to troubleshoot complex systems.
  • Strong verbal and written communication skills for effective interaction with internal teams and external stakeholders.
  • High level of accuracy and attention to detail in documentation and reporting.

If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.

Reference no.: 122-4948-2918-NW

Registration no.: 968446516E

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