Freelance CQV Engineer

Duties:

• Create validation plans.
• Perform and document impact and risk assessments, evaluating direct, indirect, and non-impact systems in complex processes.
• Maintain detailed records of qualification, validation, and change control activities for compliance audits.
• Write, edit, and execute technical commissioning, qualification, and validation documentation for equipment, systems, software, and processes under project leader guidance.
• Run test scripts and document results.
• Adhere to project schedules for assigned tasks.
• Conduct user interface testing, software verification, and alarm testing on automated systems.
• Develop, review, and execute testing documentation.
• Recommend design or process modifications based on test results.
• Understand validation documents, URS, IQ, OQ, and PQ.

Your profile:

• 5-7 years of proven CQV experience in GMP-regulated environments.
• Must have experience in Cleaning Validation.
• Strong business maturity and interpersonal skills for effective communication and collaboration.
• Ability to clearly communicate requirements with rationale to various levels within the client's organization.
• Demonstrated attention to detail and organization in project work.
• Ability to work independently on assigned tasks.
• Training in GMP and Good Documentation Practice (can be completed during onboarding).
• Intermediate proficiency in WORD (creating/editing large technical documents with styles, tables, TOCs, track changes).
• Basic proficiency in EXCEL and PowerPoint.
• Strong interpersonal skills and clear communication abilities.
  
  If you are interested please send your CV to James.Gregory@darwinrecruitment.com

Darwin Recruitment is acting as an Employment Business in relation to this vacancy.