Senior Cqv Engineer

3 days ago

Singapore ANTER CONSULTING PTE. LTD. Full time

**Essential Duties and Responsibilities:
Generates and executes CQV protocols for facilities, utilities, equipment (e.g. Autoclaves, Chambers, Rooms, HVAC, etc.), and computerized systems (e.g. Delta V, HPLCs, Spectrophotometers, etc.).

Performs basic data and statistical analysis (e.g. Temperature, Pressure, etc.).

Generates CQV plans, traceability matrices, and qualification/technical reports.

Generates qualification protocol deviations and non conformances.

Reviews vendor generated computer system qualification protocols/packages.

Generates quality deviations/CAPAs and performs investigations and root cause analysis.

Generates and revises Validation SOPs.

Generates change controls and performs validation expert assessments.

Performs validation risk-assessments.

**Education and/or Experience:
Minimum of 7 years of experience working in a cGMP regulated environment.

Minimum of 7 years of operational validation experience in a cGMP manufacturing environment.

Experience with data acquisition systems (e.g. Kaye Validator, ELLAB, Lives International, etc.)

Experience performing CQV activities for chambers, rooms, autoclaves, bioreactors, utilities (e.g. WFI, Clean Steam, Compressed Air, etc.), HVAC, benchtop laboratory equipment, etc.

**Qualifications:
Previous training on cGMP quality systems such as Change Control, CAPA, and Deviation.

Previous training and practical knowledge of cGMP regulations.

Previous training/knowledge on current risk-based validation approaches.

**Skills**:
Proficient with MS Office Word and Excel.

Excellent oral and written communication and presentation skills.

Good organizational and time management skills.

Ability to manage small projects and tasks with mínimal supervision.

Self-motivated, able to work independently, and work in a team environment.

  • Cqv Engineer

    6 days ago

    Singapore MORIMATSU PHARMADULE (SINGAPORE) PTE. LTD. Full time

    **About the Role**: Join our team as a **CQV (Commissioning, Qualification & Validation) Engineer**, supporting the start-up and validation of state-of-the-art pharmaceutical/biotech manufacturing facilities. You will work closely with project, engineering, and quality teams to ensure all systems meet GMP compliance and are ready for commercial...

  • Cqv Engineer

    1 day ago

    Singapore PM Group Full time

    : PM Group is currently looking to expand the CQV capabilities in Singapore. We are looking for CQV Engineers who will bring their expertise with them and drive our projects to completion. : - Field execution of Commissioning, Installation & Operational Qualification (IQ/OQ), Verification for downstream process equipment, CIP, & Clean utilities -...

  • Cqv Engineer

    5 days ago

    Singapore ANTER CONSULTING PTE. LTD. Full time

    **About the Role**: We are hiring an experienced CQV Engineer (Clean Utilities & HVAC) to join our our team supporting our client on the execution phase of a brownfield pharmaceutical expansion in Singapore. This role will focus on hands-on execution, coordination, and closure of qualification activities to ensure readiness for operational use and regulatory...

  • Senior CQV Engineer-Lab Equipment

    2 weeks ago

    Singapore PQE SINGAPORE PTE. LTD. Full time $90,000 - $120,000 per year

    Due to our constant growth, we are looking for a Senior CQV Engineer with strong experience in laboratory equipment and lab decommissioning activities to support our projects in Singapore.You will be responsible for:Leading commissioning, qualification, and decommissioning activities specifically related to laboratory equipment and facilities.Preparing,...

  • CQV Engineer

    4 days ago

    Singapore ANTER CONSULTING PTE. LTD. Full time $80,000 - $120,000 per year

    About the RoleWe are hiring an experienced CQV Engineer (Clean Utilities & HVAC) to join our our team supporting our client on the execution phase of a brownfield pharmaceutical expansion in Singapore. This role will focus on hands-on execution, coordination, and closure of qualification activities to ensure readiness for operational use and regulatory...

  • CQV Engineer

    1 week ago

    Singapore LANYOU TECH PTE. LTD. Full time $90,000 - $120,000 per year

    Job DescriptionThe CQV Engineer is responsible for the commissioning, qualification, and validation of CU/Cleanroom/Temperature Controlled Unit/Process systems. The role ensures that all systems are installed, tested, and qualified in compliance with cGMP, regulatory requirements, and project-specific standards.RequirementsBachelors Degree in Engineering,...

  • Senior/Lead CQV Engineer

    2 weeks ago

    Singapore INTEGRIX SOLUTIONS PTE. LTD. Full time $90,000 - $120,000 per year

    About the Role:We invite highly motivated individuals to join our team in providing support to our clients' biomanufacturing facilities. In this role, you will be tasked with performing pre-commissioning checks and detailed testing, troubleshooting process/equipment issues, preparing comprehensive reports, collaborating with cross-functional teams, and...

  • CQV Engineer

    2 weeks ago

    Singapore NO DEVIATION PTE. LTD. Full time $90,000 - $120,000 per year

    About No deviationAt 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...

  • Cqv Project Manager

    5 days ago

    Singapore PES International Full time

    **Senior CQV Project Manager** Biotechnology Manufacturing **Company**: PES International **Location**: Portsmouth, New Hampshire **Compensation**: Commensurate with Experience **About this opportunity**: PES International is an international industry leader in providing automation, commissioning, qualification, and CSV services. We have an unrivaled...

  • Senior CQV Engineer

    4 days ago

    Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time $90,000 - $120,000 per year

    Responsibilities:The incumbent will lead commissioning, qualification, and validation (CQV) activities for Lab Equipment.About You:Diploma/Degree in Engineering or Science Disciplines with at least 5 years' experience in lab equipment CSV (computer system validation).Preferably 5 – 10 years experience in analytical instrument CSV.Knowledge towards...