Validation Engineer

3 days ago

Singapore ANTER CONSULTING PTE. LTD. Full time $90,000 - $120,000 per year
About the Role

We are looking for an experienced Validation Engineer to support the Commissioning, Qualification, and Validation (CQV) activities for an ongoing fill-finish expansion project. This mid-level role will involve executing qualification protocols, supporting commissioning activities, and ensuring all systems (utility and process equipment) meet the required regulatory and operational standards.

Key Responsibilities
  • Execution of Qualification Protocols: Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for utility systems (e.g., HVAC, WFI, purified water, compressed air) and process equipment (e.g., filling lines, capping systems, packaging equipment).
  • Commissioning Support: Assist in commissioning activities for systems and equipment, ensuring adherence to specifications, regulations, and operational requirements.
  • Documentation: Ensure that all validation documentation is accurate, complete, and in compliance with GMP and regulatory requirements. Review and approve qualification reports, test results, and associated documentation.
  • Deviation Management: Support the investigation and resolution of any deviations identified during the qualification process and ensure proper documentation of corrective actions.
  • Cross-Functional Collaboration: Work closely with engineering, operations, and quality assurance teams to ensure a smooth validation process and meet project timelines.
  • System Monitoring: Track progress and maintain a system to monitor and report validation status and compliance during the C&Q phase.
  • Training and Support: Provide support and guidance to junior validation engineers and help with training on validation activities and protocols.
Key Requirements
  • Education: Bachelor's degree in Engineering (Mechanical, Chemical, Biochemical, or related field).
  • Experience: Minimum of 5 years of experience in validation, commissioning, and qualification within pharmaceutical or biotech environments.
  • Technical Skills:

Strong hands-on experience with utility systems (WFI, HVAC, purified water, compressed air) and process equipment (filling, capping, and packaging systems).

Solid understanding and experience with IQ/OQ/PQ protocols.

Familiar with GMP and GxP regulations and their application to qualification activities.
- Attention to Detail: Ability to ensure the thorough execution of qualification protocols and proper documentation of deviations and corrective actions.
- Communication Skills: Good written and verbal communication skills to work with project teams and document validation results.

  • Validation Engineer

    2 weeks ago

    Singapore Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Engineer (Validation)

    4 days ago

    Singapore Lonza Biologics Porriño SLU Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Validation Engineer

    4 days ago

    Singapore ONE STOP ENGINEERING PTE. LTD. Full time

    Validation engineers manage, inspect, calibrate, test and modify the instrumentation, equipment, mechanics and procedures used in manufacturing. A critical aspect of their job is documenting this process so there is evidence that systems are operating safely and efficiently. Validation engineers can be found in a range of industries, including aerospace,...

  • Validation Engineer

    6 days ago

    Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    We are looking for a Validation Engineer to support a range of qualification and validation activities across critical equipment and controlled environments. This role involves the execution of temperature mapping, equipment validation, protocol development, and performance verification to ensure compliance with regulatory standards and internal quality...

  • Engineer (Validation)

    7 days ago

    Singapore Lonza Full time $80,000 - $120,000 per year

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • VALIDATION ENGINEER

    1 week ago

    Singapore Mikron Group Full time

    Overview Validation Engineer Join our team as a Validation Engineer and play a key role in ensuring our products and processes meet the highest standards of quality and compliance. This position offers exposure to diverse projects and the opportunity to collaborate across regional teams. Purpose of the Role Support the Quality and Validation Manager Asia in...

  • Validation Engineer

    2 weeks ago

    Singapore Coalesce Management Consulting Full time $90,000 - $120,000 per year

    Position: Validation EngineerWe are Coalesce Management Consulting - 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 Validation Engineer to support...

  • Validation engineer

    2 weeks ago

    Singapore GAM-X ENGINEERING SERVICES PTE. LTD. Full time $60,000 - $120,000 per year

    Responsibilities:Hands-on experience and understanding of automated systems supporting manufacturing, IT infrastructure, Engineering and operations.Strong understanding and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.Promoting GMP awareness and a culture of continuous improvement...

  • Validation Engineer

    2 days ago

    Singapore ANTER CONSULTING PTE. LTD. Full time

    **Key responsibilities**: - Perform Process Validation activities. Schedule own tasks to be performed as well as tasks for other Specialists as determined by the Validation Manager - Perform change control assessments for GMP equipment and associated validation activities to ensure compliance with regulatory requirements - Program, organize, and maintain...

  • Validation Engineer

    3 days ago

    Singapore J P INFOTEC PTE. LTD. Full time

    Si Validation Engineer : Programming language – C & Python Good Understanding of SOC architectures and validation of Integrated IP's Test plan development and test content writing based on design specifications, architecture document & end use case scenarios for SOC's Silicon bring up, initial power-on, bootup & functional testing Preferred Memory & PCIE...