Qc - Validation Engineer

16 hours ago


Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time

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.

**Requirements**:

- 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.



  • Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    **Position: QC Validation Engineer** At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists. We are currently expanding our team and are looking for a QC Validation...


  • Singapore No deviation Pte Ltd Full time

    **About No deviation** At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to...


  • Singapore PharmEng Technology Pte Ltd Full time

    Proficient in the following: 1. Software upgrade qualification 2. Empower 3. Temperature mapping 4. Data integrity. **Requirements**: - 3-5 years minimum experience in software validation - Preferred someone who has experience with QC Software validation and temperature mapping (know how to use Kaye Validator/templates) **Job Type**: Contract Contract...


  • Singapore No deviation Pte Ltd. Full time

    About No deviation At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful...


  • Singapore NO DEVIATION PTE. LTD. Full time

    About No deviation At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to...


  • Singapore No Deviation Pte Ltd Full time

    Responsibilities: Delegate for QC system owners to support the following tasks: - Support validation lifecycle documentation review and approvals. - Support commissioning/qualification documentation review and closures including exception - review and closures. - Provides guidance and direction on commissioning / qualification activities - Support change...

  • Validation Engineer

    2 weeks ago


    Singapore Triton AI Pte Ltd Full time

    **Responsibilities**: - Conduct cleaning validation activities with a specific emphasis on CIP for pharmaceutical manufacturing equipment and processes. - Develop and execute cleaning validation protocols, ensuring compliance with regulatory requirements and industry standards, especially in the context of procedures. - Collaborate with cross-functional...


  • Singapore PES International Full time

    PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational...


  • Singapore Triton AI Pte Ltd Full time

    Perform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on Process Equipment, CIP / SIP, Process Manufacturing and related business processes including Quality Operations and Supply Chain Operations, Method validation (analytical chemistry, biochemistry, microbiological) & Enterprise system...


  • Singapore GDMC Full time

    **Key **Responsibilities** Your responsibilities include, but are not limited to: - This position will support operational readiness of a new facility. - Establishment of QA Validation procedures (drafting and reviewing QA Validation functional SOPs). - Act as SME to develop commissioning, validation and qualification procedures, train and guide site...