Commissioning and Qualification Specialist

2 weeks ago


Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time
Job Summary

We are seeking a highly skilled Commissioning and Qualification Specialist to join our team at PHARMENG TECHNOLOGY PTE. LTD. The successful candidate will be responsible for providing technical services to our site Technical Services management, contributing to increased throughput of commissioning and qualification activities across the site.

Key Responsibilities
  • Commissioning and Qualification: Provide direct services to site Technical Services management, contributing to increased throughput of commissioning and qualification activities across the site.
  • Validation Activities: Collaborate with Technical Services management while independently performing required validation activities.
  • Support to C&Q Activities: Support C&Q activities across the site as directed by site Technical Services management.
  • Documentation Review: Review commissioning and qualification documentation for accuracy, technical soundness, and compliance with site and regulatory guidelines.
  • Project Contribution: Contribute to projects, including new facilities/equipment startup, commissioning, manufacturing equipment qualification, laboratory equipment qualification, and computerized and automation systems.
  • User Requirement and Functional Specifications: Assist in the development of user requirement and functional specifications.
  • Commissioning and Qualification Documentation: Generate and execute commissioning and qualification documentation, including demonstration batches, thermal studies, validation studies, software validation, and final reports.
  • System Acceptance and Release: Recommend to management the acceptance and release of qualified systems.
  • Technical Information and Support: Actively participate during all phases of validation projects, providing technical information to others.
  • Document Review and Compliance: Review technical and quality system documents, ensuring compliance with validation principles and regulatory requirements.
  • Documentation Review and Compliance: Review various documentation and drawings to ensure changes meet quality and validation requirements and comply with regulations and standards.
  • Technical Assistance and Troubleshooting: Provide technical assistance during investigations of process/equipment/cleaning/validation issues.
  • Problem Solving and Solutions: Support, investigate, and troubleshoot problems, determining possible solutions.
  • System Deviations and Non-Conformances: Provide effective solutions for the management of system deviations and non-conformances.
Requirements
  • Education: Bachelor's degree in a technical field (engineering, biology, chemistry, pharmacy).
  • Experience: 4 - 7 years of applied technical experience in the pharmaceutical or biotech industries.
  • Commissioning, Qualification, and Validation Experience: Hands-on commissioning, qualification, and validation experience in at least two of the following disciplines: Facilities (including design, flow analysis), Utilities (including clean steam, clean air, compressed air and gases, process waste systems), major equipment, process/cleaning and equipment validation/qualification, or computer software validation.
  • Good Manufacturing Practice Validation Requirements: Firm understanding of good manufacturing practice validation requirements/guidelines and current industry practices.


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