Commissioning and Qualification Specialist

4 weeks ago


Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time
Roles & Responsibilities

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

Tell employers what skills you have

Water
Technical Assistance
Quality System
HVAC
Throughput
Process Validation
Chemistry
Biology
Equipment Qualification
Writing
Regulatory Requirements
Laboratory
Manufacturing
Technical Services Management
Commissioning
Compressed Air

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