Validation Engineer (CQV)

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

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.