Commissioning and Qualification Specialist

at  PHARMENG TECHNOLOGY PTE LTD

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, 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), 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.
• Firm understanding of good manufacturing practice validation requirements/guidelines and current industry practices.

• 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, 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