Your new company
Client is an expert in automation and digital systems for pharmaceutical and biotech manufacturing, seeking to hire a yearly contract renewable CQV Engineer.
- Duration: Yearly Contract
- Salary: open for negotiation
Your new role
We are seeking an experienced CQV Engineer with experience in Analytical / QC Laboratory Equipment, you will play a critical role in preparing, reviewing and executing qualification protocols and supporting lifecycle documentation.
- Prepare, review, and execute qualification protocols and supporting lifecycle documentation, including risk assessments, IQ/OQ/PQ protocols, traceability matrices, deviation records, and final qualification reports.
- Perform commissioning, qualification, and validation activities for analytical and QC laboratory equipment, such as HPLC/UHPLC systems, gas chromatographs, spectrophotometers, TOC analyzers, dissolution testers, pH and conductivity meters, laboratory balances, incubators, ovens, refrigerators, and other GMP-regulated laboratory systems.
- Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), calibration activities, installation verification, vendor documentation review, and equipment turnover processes.
- Coordinate and execute temperature mapping studies for controlled-temperature laboratory equipment and storage systems, as required.
- Verify computerized system functionality and data integrity controls, including audit trails, user access management, electronic signatures, security configurations, backup and recovery processes, and time synchronization.
- Support interface and integration verification involving systems such as LIMS, Chromatography Data Systems (CDS), MES, PCS, and data historian platforms where applicable.
- Manage deviations, CAPAs, change controls, punch-list items, and qualification-related discrepancies through timely closure.
- Collaborate with Quality Assurance, Quality Control, Engineering, Automation, IT, vendors, and project teams to ensure successful execution of qualification activities and project deliverables.
- Maintain complete, accurate, and audit-ready documentation in compliance with GMP requirements and Good Documentation Practices (GDP).
What you'll need to succeed
- Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, or a related scientific or technical discipline.
- Minimum 5 years of hands-on Commissioning, Qualification, and Validation (CQV) experience supporting analytical or QC laboratory equipment within pharmaceutical, biotechnology, or other GMP-regulated environments.
What you'll get in return
This is an exciting opportunity to contribute to large scale pharmaceutical projects.
What you need to do now
If you're interested in this role, click apply now to forward an up-to-date copy of your CV, or call Rachel at Hays on +65 6027 1923 or email [Confidential Information] for a confidential discussion.
Referrals are welcome.
Registration ID No. R24121588| EA License number: 07C3924 | Company Registration No. 200609504D
