Validation Consultant

2 weeks ago

Singapore Triton AI Pte Ltd Full time

Perform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on one or more of the following areas:

- 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 (LIMS, QMS)
- Develop risk assessment, system impact assessments, protocols and reports that support the qualification and validation requirements in the industry.
- Develop validation protocols using a science and risk -based approach that meets regulatory requirements and industry best practices.
- Review, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to management.
- Investigate deviations, write investigation reports and create summary reports.
- Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

**Requirements**:

- Bachelor’s degree in technical discipline such as Engineering or Science or with experience relevant to the Job Description. Graduates of related discipline may also apply.
- Minimum 3 years of experience in pharmaceutical industry
- Experiences in commissioning, qualification, validation, quality systems, quality operations, manufacturing, engineering, technology transfer.
- Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4 and other regulatory requirements preferred
- Experience with investigations into manufacturing / laboratory deviations and determination of product impact potential, root cause and corrective/preventive actions.
- Strong knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.

**Benefits**:

- Up to $6000 with 2 months Variable Bonus, Permanent Position
- West Singapore
- Pharmaceutical Industry Experience is a MUST
- Experiences in multiple CQV discipline (such as CIP, SIP)

Reg No. R23111870 Triton AI Pte Ltd License no. 21C0661

  • Consultant Compliance

    2 days ago

    Singapore Arcondis Full time

    ARCONDIS is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and digital...

  • QA Validation

    2 weeks ago

    Singapore PSC BIOTECH PTE. LTD. Full time

    Develop and execute IQ, OQ and PQ protocols for product, processes, facilities, software and equipment within the facility. - Write reports summarizing results and statistics for all validation projects. - Review existing validation reports and identifies gaps for compliance. Develop strategies and plans to close the gaps in an efficient and technical...

  • Junior Consultant

    16 hours ago

    Singapore NNIT SINGAPORE PTE. LTD. Full time

    About Us Headquartered in Denmark, NNIT Singapore Pte Ltd is a rapidly expanding leader in life science consulting, delivering innovative solutions across Singapore and the broader Asian region since 2011. We provide comprehensive, end-to-end services tailored to life science clients, covering every aspect of the value chain-from laboratory environments and...

  • 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...

  • Junior Consultant

    6 days ago

    Singapore NNIT SINGAPORE PTE. LTD. Full time

    About Us Headquartered in Denmark, NNIT Singapore Pte Ltd is a rapidly expanding leader in life science consulting, delivering innovative solutions across Singapore and the broader Asian region since 2011. We provide comprehensive, end-to-end services tailored to life science clients, covering every aspect of the value chain—from laboratory environments...

  • QC Validation Engineer

    16 hours ago

    Singapore Coalesce Management Consulting Pte. Limited Full time

    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. Position: QC Validation Engineer Job Description: We are currently expanding our team and are looking for a QC...

  • QA Validation Engineer

    2 days ago

    Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    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. **Position: QA Validation Engineer** We are currently expanding our team and are looking for a QA Validation...

  • Lab Equipment Validation Consultant

    16 hours ago

    Singapore PQE SINGAPORE PTE. LTD. Full time

    Due to our constant growth, we are looking for a Lab Validation Equipment / CQV Engineer to support a strategic decommissioning and qualification project in a GMP-regulated laboratory located in Singapore. You will be responsible for: Supporting the decommissioning of analytical instruments in a GMP-regulated laboratory, ensuring compliance with internal...

  • Senior Validation Engineer

    2 weeks ago

    Singapore No Deviation Pte Ltd Full time

    No 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...

  • Lab Equipment Validation Consultant

    1 week ago

    Singapore PQE SINGAPORE PTE. LTD. Full time $104,000 - $130,878 per year

    Due to our constant growth, we are looking for a Lab Validation Equipment / CQV Engineer to support a strategic decommissioning and qualification project in a GMP-regulated laboratory located in Singapore.You will be responsible for:Supporting the decommissioning of analytical instruments in a GMP-regulated laboratory, ensuring compliance with internal...