Technical Validation Specialist

4 days ago

Singapore beBeeValidation Full time $90,000 - $120,000
Commissioning, Qualification and Validation (CQV) Specialist

Pharmaceutical companies in the Life Science industry require skilled professionals to oversee commissioning, qualification, and validation processes. As a Commissioning, Qualification and Validation (CQV) specialist, you will play a crucial role in ensuring compliance with regulatory guidelines.

Key Responsibilities:

  • Develop, review, and execute Commissioning and Qualification (C&Q) documentation, including Qualification Plans, Commissioning and Qualification Protocols, Data Integrity Assessments, Security Assessments, and Qualification Summary/Completion Reports.
  • Ensure all documentation complies with Good Documentation Practices (GDP), GxP, and regulatory requirements.
  • Capture and align user requirements for the qualification of new laboratory and production equipment.
  • Participate in risk assessments and define qualification strategies in alignment with project and regulatory requirements.
  • Liaise with equipment vendors and service providers to review, assess, and approve vendor-supplied documentation such as Installation and Operational Qualification protocols.
  • Coordinate execution of vendor IOQs and support resolution of technical or compliance issues.
  • Support deviation management, change control, and CAPA activities related to qualification and commissioning projects.
  • Contribute to continuous improvement initiatives to streamline CQV processes and enhance efficiency.
Requirements & Skills:
  • Bachelor's degree in Engineering, Life Sciences, or a related discipline.
  • Experience in Commissioning, Qualification, and Validation (CQV) in a regulated pharmaceutical/biopharma environment.
  • Knowledge of regulatory guidelines (FDA, EMA, ICH).
  • Strong technical writing, analytical, and problem-solving skills.
  • Excellent coordination, communication, and stakeholder management abilities.

This is an opportunity for a dedicated professional to make a significant impact in ensuring compliance and driving process improvements in a dynamic Life Science industry setting.

You are expected to possess excellent collaboration, problem-solving, and analytical skills, with strong attention to detail and ability to work well under pressure.

As a key player in this team, you will be responsible for maintaining high-quality standards in documentation, coordination, and communication.

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