QC - Validation Engineer
2 weeks ago
We are looking for a QC Engineer to support validation of analytical laboratory instruments and computerized systems in a GMP-regulated environment. The role focuses on ensuring compliance with 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity requirements.
Key Responsibilities- Plan, execute, and document qualification/validation of analytical instruments (e.g., HPLC, GC, UV, CDS, LIMS, Empower).
- Prepare, review, and execute CSV deliverables such as URS, IQ/OQ/PQ, RTM, and summary reports.
- Perform data integrity assessments and ensure compliance with ALCOA+, GDP, and cGMP guidelines.
- Draft, review, and maintain validation-related SOPs for QC systems and equipment.
- Support audits and inspections with accurate validation documentation.
- Collaborate with QC, QA, and IT to ensure readiness for system lifecycle activities (periodic review, change control, upgrades, cyber-resilience).
Contribute to continuous improvement initiatives to strengthen QC lab compliance.
- Bachelor's degree or higher in Chemistry, Life Sciences, Engineering, or related field.
- 5–10 years' experience in CSV/validation of analytical instruments within QC labs in pharmaceutical/biotech.
- Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, Annex 11 , and data integrity frameworks.
- Experience with microbiology analytical equipment is an advantage.
- Hands-on use of Kneat or other e-validation platforms preferred.
- Strong technical documentation and troubleshooting skills.
- Able to work cross-functionally and support audit readiness.
-
Qc - Validation Engineer
6 days ago
Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full timeWe are looking for a QC Engineer to support **validation of analytical laboratory instruments and computerized systems**in a GMP-regulated environment. The role focuses on ensuring compliance with 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity requirements. **Key Responsibilities**: - Plan, execute, and document qualification/validation of...
-
Qc Validation Specialist
13 hours ago
Singapore No deviation Pte Ltd Full timeNo Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services. We strongly uphold our core...
-
Qc Validation Specialist
13 hours ago
Singapore No Deviation Pte Ltd Full timeNo Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services. We strongly uphold our core...
-
QC Engineer
1 week ago
Singapore Unison Group Full time $90,000 - $120,000 per yearRole OverviewWe are seeking a QC Engineer with strong experience in Computer System Validation (CSV) for analytical laboratory instruments /equipment. The role ensures compliance with 21 CFR Part 11, data integrity, and global validation standards in a regulated GMP environment.Key ResponsibilitiesLead CSV activities for analytical equipment or instruments...
-
QC Engineer
5 days ago
Singapore RISKDATA CONSULTING PTE. LTD. Full time $90,000 - $120,000 per yearWe are seeking a QC Engineer with strong experience in Computer System Validation (CSV) for analytical laboratory instruments /equipment. The role ensures compliance with 21 CFR Part 11, data integrity, and global validation standards in a regulated GMP environment.Key ResponsibilitiesLead CSV activities for analytical equipment or instruments and lab...
-
Qc In-coming
13 hours ago
Singapore GMP Group Full time**QC In-coming & Process Validation Manager** Our client is the renowned manufacturer and supplier of medical & healthcare products in Singapore. They are committed to enhance the quality of life through constant product innovation and quality enhancement. Join them to take pride of what you can do to improve people’s life. *** **Responsibilities**: -...
-
QC Expert
1 week ago
Singapore MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD Full timeQC Expert (Lab Validation/ Decommissioning/ Pharma)Location : Gul Circle Salary up to $7,000 depending on experience Industry : MNC Pharmaceutical Our clients deliver 4.3 billion healthcare solutions annually and with your talent, we can do even more to protect and support patients Responsibilities Being representative of the site in the CoPs led by the...
-
QC Engineer
1 week ago
Singapore Unison Group Full time $80,000 - $120,000 per yearWe are looking for a QC Engineer with hands-on expertise in temperature mapping of controlled chambers. The role supports qualification, documentation, and lifecycle compliance of temperature-controlled environments in a GMP-regulated setting.Plan, execute, and document temperature mapping studies for chambers (cold rooms, freezers, incubators, stability...
-
Senior Validation Engineer
1 week ago
Singapore NUSANTARA PRIME CONSULTING PTE LTD Full timeThe Senior Validation Engineer is responsible for the qualification or requalification of laboratory equipment within the targeted schedule. **Responsibilities**: - Responsible for managing and writing of qualification related documentation but not limited to Qualification Plan and IQ, OQ, PQ and ERES Test Scripts for QC laboratory equipment (lab bench and...
-
QC Associate
6 days ago
Singapore MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD Full timeOverview QC Associate - System Support (Equipment Qualification/ Validation/Pharma)Location : Gul Circle Salary Up to $4,500 depending on experience Completion Bonus 1 Month Our client delivers vital healthcare solutions worldwide, powered by the precision and dedication of its Manufacturing & Supply teams. With your talent, they can expand their...