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.
