Senior CQV Professional

1 week ago

Dublin, Dublin City, Ireland beBeeValidation Full time
Job Summary

We are seeking a talented Commissioning, Qualification, and Validation (CQV) Engineer to join our team. In this role, you will be responsible for ensuring the commissioning, qualification, and validation of equipment, systems, and processes used in drug substance manufacturing.

This is a mid-senior level position that requires excellent problem-solving, analytical, project management, and organizational skills. You will work closely with cross-functional teams to support the successful delivery of projects.

About the Role
  • CQV Engineer will develop and execute commissioning plans for new and existing equipment and systems.
  • Perform equipment start-up and troubleshooting to ensure proper operation.
  • Document commissioning activities and results.
  • CQV Engineer will develop and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, and systems.
  • Evaluate qualification data and prepare comprehensive reports.
  • CQV Engineer will develop and execute validation protocols for processes and computer systems.
  • Conduct risk assessments and gap analyses to identify critical process parameters and control strategies.
Key Responsibilities
  • Manage multiple CQV projects simultaneously, ensuring timely completion and adherence to project timelines.
  • Coordinate with cross-functional teams to ensure seamless project execution.
  • Provide regular project updates and status reports to stakeholders.
Requirements
  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • Experience in CQV within the pharmaceutical or biotechnology industry.
  • Proficiency in developing and executing IQ/OQ/PQ protocols.
  • Familiarity with risk-based approaches to validation.
  • Excellent communication and interpersonal skills.
Preferred Qualifications
  • Certification in Project Management.
  • Experience with electronic documentation systems and validation lifecycle management software.
Working Conditions

This position may require occasional travel to other sites or manufacturing facilities.

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