CQV Validation Engineer - Pharma & GMP

TRAQUE PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Part time

Job summary

TRAQUE PTE. LTD. in Singapore is seeking Validation Engineers with CQV experience to support a major pharmaceutical manufacturing project.

The role involves executing commissioning, qualification and validation activities within a GMP environment and collaboration with pharmaceutical, biotech or life sciences teams. Candidates should have 2+ years in CQV/validation, hands-on field CQV execution, and knowledge of cGMP and regulatory requirements.

Qualifications

• Bachelor's degree in Engineering, Science, Chemistry, Pharmacy or a related discipline.
• Minimum 2 years of relevant experience in Validation, Commissioning & Qualification (CQV), Commissioning, Qualification or a closely related role.
• Experience in a pharmaceutical, biotech, life sciences or other GMP-regulated environment is preferred.
• Practical field CQV/validation execution experience.
• Familiarity with risk-based validation/qualification methodologies.
• Experience preparing, reviewing or executing validation/qualification documentation and protocols.
• Good understanding of cGMP and applicable regulatory requirements.
• Strong interpersonal, communication and coordination skills.
• Ability to work independently and effectively within multidisciplinary teams.

Responsibilities

• Execute CQV activities according to approved project plans, procedures and GMP requirements.
• Support the development and execution of CQV/validation strategies, protocols, test scripts and related documentation.
• Plan and execute CQV activities for assigned systems and areas.
• Coordinate CQV activities with Engineering, Construction, Automation, Electrical, Instrumentation, Operations, HSE and external vendors/contractors.
• Support the development and maintenance of CQV schedules and ensure activities are completed according to project milestones.
• Prepare, review and execute CQV/validation documentation, including protocols, test scripts, reports and qualification documents.
• Review and manage discrepancies/deviations identified during CQV execution and support investigation and remediation activities.
• Support change control activities and assess impacts on quality, compliance, cost and schedule.
• Liaise with vendors and contractors regarding commissioning, qualification and validation activities.
• Participate in system walkdowns, mechanical completion activities and punch-list/snag-list reviews.
• Ensure CQV activities are performed safely and in accordance with site EHS and quality requirements.
• Provide updates on CQV progress, issues, risks and upcoming activities to project stakeholders.
• Ensure CQV and validation activities comply with applicable cGMP, regulatory and industry requirements.

Skills

Interpersonal skills

Coordination skills

Team collaboration

English proficiency

Education

Bachelor's degree

Job description

TRAQUE PTE. LTD. in Singapore is seeking Validation Engineers with CQV experience to support a major pharmaceutical manufacturing project.

The role involves executing commissioning, qualification and validation activities within a GMP environment and collaboration with pharmaceutical, biotech or life sciences teams. Candidates should have 2+ years in CQV/validation, hands-on field CQV execution, and knowledge of cGMP and regulatory requirements.