Validation Engineer (CQV)

TRAQuE Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

TRAQuE Pte Ltd in Singapore seeks Validation Engineers with Commissioning & Qualification (CQV) experience on a contract basis. The role covers executing CQV activities in a GMP-regulated environment, with emphasis on CQV strategies, protocols and documentation.

Ideal candidates will have 2+ years in CQV/validation within pharma or life sciences and strong teamwork across multidisciplinary sites. Opportunities to contribute to major projects and ensure regulatory compliance are available.

Qualifications

• Bachelor's degree in Engineering, Science, Chemistry, Pharmacy or a related discipline.
• Minimum 2 years of relevant CQV/validation experience.
• Experience in pharmaceutical, biotech or GMP-regulated environments is preferred.

Responsibilities

• Execute commissioning, qualification and validation activities per project plans and GMP.
• Develop and execute C&Q/validation strategies, protocols and test scripts.
• Plan, execute and document CQV activities for assigned systems and areas.
• Coordinate CQV with Engineering, Construction, Automation, and vendors.
• Prepare, review and approve CQV/validation documentation and reports.
• Review discrepancies and support investigations and remediation.
• Support change control and assess impacts on quality, cost and schedule.
• Liaise with vendors and contractors on CQV activities.
• Participate in walkdowns, mechanical completion and punch-list reviews.
• Ensure CQV activities comply with cGMP, regulatory and site quality requirements.

Skills

CQV experience

Interpersonal skills

Communication skills

Coordination skills

Independent work

Education

Bachelor's degree in Engineering, Science, Chemistry, Pharmacy or related

Job description

Location: Singapore
Employment Type: Contract
Experience Level: Junior to Senior
Minimum Experience: 2 years

Role Overview

We are looking for Validation Engineers with Commissioning & Qualification (CQV) experience to support a major pharmaceutical manufacturing project in Singapore.

The successful candidates will support and execute commissioning, qualification and validation activities within a GMP-regulated environment. Candidates from pharmaceutical, biotech or other life sciences industries with relevant CQV/validation experience are encouraged to apply.

Key Responsibilities

• Execute commissioning, qualification and validation activities in accordance with approved project plans, procedures and GMP requirements.
• Support the development and execution of C&Q/validation strategies, protocols, test scripts and related documentation.
• Plan and execute commissioning, qualification and validation 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.

Requirements

• 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.
• Ability to work within strict project deadlines.
• Good written and spoken English.

Preferred Qualifications

• Experience supporting pharmaceutical manufacturing or greenfield projects.
• Experience working with multidisciplinary engineering and project teams.
• Experience coordinating with vendors, contractors or third parties.
• Candidates with leadership, SME or extensive CQV experience may be considered for senior-level positions.