Senior CQV Engineer: GMP Validation & Compliance

PharmEng Technology; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

PharmEng Technology in Singapore is seeking an experienced Commissioning, Qualification and Validation (CQV) Engineer to support GMP projects in the Life Sciences sector. You will draft and execute CQV documentation, coordinate vendor activities, and ensure compliance with GDP, GxP and regulatory guidelines.

Key duties include collaboration with QC SMEs, defining qualification strategies, and driving continuous improvement while upholding data integrity and cybersecurity during system

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related discipline.
• Experience in CQV in a regulated (GMP) pharmaceutical/biopharma environment.
• Knowledge of regulatory guidelines (FDA, EMA, ICH, ISPE, GAMP 5).
• Strong technical writing, analytical, and problem-solving skills.
• Excellent coordination, communication, and stakeholder management abilities.

Responsibilities

• Draft, review, and execute CQV documentation, including plans, CQV protocols, DIA, SA, and QSR/CVSR.
• Ensure documentation complies with GDP, GxP, and regulatory guidelines.
• Maintain records of test execution and deviations.
• Collaborate with QC SMEs to capture user requirements for equipment qualification.
• Define qualification strategies in alignment with project and regulatory requirements.
• Liaise with equipment vendors to review IOQ documentation and review vendor-supplied materials.
• Coordinate execution of vendor IOQs and resolve technical or compliance issues.
• Ensure vendor activities align with site standards and project timelines.
• Support deviation management, change control, and CAPA activities related to qualification and commissioning.
• Contribute to continuous improvement initiatives to streamline CQV processes and enhance efficiency.
• Ensure adherence to data integrity principles and cybersecurity requirements during system qualification.

Skills

Technical writing

Analytical thinking

Problem solving

Coordination/communication

Stakeholder management

Education

Bachelor’s degree in Engineering, Life Sciences, or related discipline

Job description

PharmEng Technology in Singapore is seeking an experienced Commissioning, Qualification and Validation (CQV) Engineer to support GMP projects in the Life Sciences sector. You will draft and execute CQV documentation, coordinate vendor activities, and ensure compliance with GDP, GxP and regulatory guidelines.

Key duties include collaboration with QC SMEs, defining qualification strategies, and driving continuous improvement while upholding data integrity and cybersecurity during system