Commissioning and Qualification Specialist

3 days ago

Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

Responsibilities: _
- Provide direct services to site Technical Services management, contributing to increased throughput of commissioning and qualification activities across the site.
- Collaborate with Technical Services management while independently performing required validation activities.
- Support C&Q activities across the site as directed by site Technical Services management.
- Review commissioning and qualification documentation for accuracy, technical soundness, and compliance with site and regulatory guidelines.
- Contribute to projects, including new facilities/equipment startup, commissioning, FAT, manufacturing equipment qualification, laboratory equipment qualification, and computerized and automation systems.
- Assist in the development of user requirement and functional specifications.
- Generate and execute commissioning and qualification documentation, including demonstration batches, thermal studies, validation studies, software validation, and final reports.
- Recommend to management the acceptance and release of qualified systems.
- Actively participate during all phases of validation projects, providing technical information to others.
- Review technical and quality system documents, ensuring compliance with validation principles and regulatory requirements.
- Review various documentation and drawings to ensure changes meet quality and validation requirements and comply with regulations and standards.
- Provide technical assistance during investigations of process/equipment/cleaning/validation issues.
- Support, investigate, and troubleshoot problems, determining possible solutions.
- Provide effective solutions for the management of system deviations and non-conformances.
- Job Requirements: _
- Bachelor's degree in a technical field (engineering, biology, chemistry, pharmacy).
- 4 - 7 years of applied technical experience in the pharmaceutical or biotech industries.
- Hands-on commissioning, qualification, and validation experience in at least two of the following disciplines: Facilities (including design, flow analysis, HVAC), Utilities (including WFI / RO/ purified water, clean steam, clean air, compressed air and gases, process waste systems), major equipment, process/cleaning and equipment validation/qualification, or computer software validation.
- Firm understanding of cGMP validation requirements/guidelines and current industry practices.
- For CQV Specialists in QA: _

**1 Person**:

- Oversight of all CQV activities requires 1 experienced individual to oversee CSV, with 7 - 8 years of experience in CSV or QA oversight.
- CSV for writing validation PLANS ONLY, not protocols for different CSV.
- May keep 1 or 2 contractors to support process validation activities, reviewing protocols and reports after the contract is over.

**2 Persons**:

- 2 QA individuals providing oversight for C&Q activities, IOQP, etc., on manufacturing systems, facilities, utilities, process equipment (e.g., P&I review), and reviewing reports

**2 Persons**:

- Another 2 for QC oversight, overseeing AMV, C&Q activities of Lab systems, reviewing reports

  • Commissioning, Qualification and Validation

    31 minutes ago

    Singapore PES International Full time

    **Process Engineering Specialists** **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...

  • Opportunity for Commissioning and Qualification Excellence

    2 weeks ago

    Singapore beBeeValidation Full time $40,000 - $80,000

    **Job Title:** Junior Validation EngineerWe are seeking a skilled and detail-oriented professional to join our team as a Junior Validation Engineer. In this role, you will be responsible for supporting the generation and review of commissioning and qualification protocols.**Key Responsibilities:*Supporting the generation and review of commissioning and...

  • Senior Commissioning, Qualification

    7 days ago

    Singapore PM ASIA PROJECT SERVICES PTE. LTD. Full time

    Roles & Responsibilities PM Singapore is currently looking to expand the CQV capabilities. This role will be supporting one of our many clients in the field of commissioning, qualification and validation work within the Life Sciences space. Your day to day role would involve the following activities: Planning, Performance, and Coordination of Computer...

  • Commissioning, Qualification and Validation Engineer

    2 weeks ago

    Singapore Wood Full time

    Principal Commissioning Qualification & Validation Engineer Join to apply for the Principal Commissioning Qualification & Validation Engineer role at Wood . As a CQV Engineer, you will be responsible for ensuring the successful commissioning, qualification, and validation of equipment, systems, and processes within client's pharmaceutical plant. You will...

  • Senior Commissioning, Qualification Expert

    1 week ago

    Singapore beBeeCqv Full time

    Job Title: Senior Commissioning, Qualification Expert We are seeking an experienced professional to lead our commissioning and qualification efforts. As a CQV expert, you will plan, coordinate, and execute the validation of computer systems, equipment, and analytical instruments. Key Responsibilities: Commissioning and Qualification: Develop and...

  • Commissioning, Qualification and Validation Engineer

    3 days ago

    Singapore John Wood Group Full time

    As a CQV Engineer, you will be responsible for ensuring the successful commissioning, qualification, and validation of equipment, systems, and processes within client’s pharmaceutical plant. You will play a crucial role in maintaining compliance with industry regulations, optimizing operational efficiency, and ensuring the quality and safety of the...

  • Senior Commissioning, Qualification

    4 days ago

    Singapore PM ASIA PROJECT SERVICES PTE. LTD. Remote Work Freelance Full time

    PM Singapore is currently looking to expand the CQV capabilities. This role will be supporting one of our many clients in the field of commissioning, qualification and validation work within the Life Sciences space.Your day to day role would involve the following activities: Planning, Performance, and Coordination of Computer System Validation, Equipment...

  • Senior Commissioning, Qualification

    3 days ago

    Singapore PM ASIA PROJECT SERVICES PTE. LTD. Full time $104,000 - $130,878 per year

    PM Singapore is currently looking to expand the CQV capabilities. This role will be supporting one of our many clients in the field of commissioning, qualification and validation work within the Life Sciences space. Your day to day role would involve the following activities: Planning, Performance, and Coordination of Computer System Validation,...

  • Principal Commissioning Qualification

    2 days ago

    Singapore Wood Full time

    Principal Commissioning Qualification & Validation Engineer Join to apply for the Principal Commissioning Qualification & Validation Engineer role at Wood . As a CQV Engineer, you will be responsible for ensuring the successful commissioning, qualification, and validation of equipment, systems, and processes within client’s pharmaceutical plant. You will...

  • Commissioning & Qualification (C&q) Engineer

    2 days ago

    Singapore ANTER CONSULTING PTE. LTD. Full time

    **About the Role**: We are seeking a skilled and driven Commissioning & Qualification (C&Q) Engineer to support our pharmaceutical clients on CAPEX projects across Singapore. You will play a key role in the qualification of critical systems, ensuring compliance with GMP and regulatory standards during facility and equipment commissioning. **Key...