Commissioning & Qualification (C&Q) Specialist (North Region)

• Generate comprehensive Validation Plans for systems and equipment
• Develop and maintain System Design Lifecycle (SDLC) documentation, including but not limited to: User Requirements Specifications (URS), System Risk Assessments, ERES CFR Part 11 compliance documentation, and GxP Assessments
• Develop, execute, and review Installation and Operational Qualification (IOQ) protocols
• Generate and approve protocol deviation reports as necessary
• Verify system drawings for accuracy and compliance
• Create and maintain Preventive Maintenance and Calibration forms, including training materials
• Develop Standard Operating Procedures (SOPs)
• Conduct Cleanability Assessments and document findings
• Prepare Final Summary Reports detailing validation outcomes and compliance status
• Collaborate with cross-functional teams to ensure project timelines and quality standards are met

• Proven experience in Validation Plan generation and execution
• Expertise in developing SDLC documentation such as URS, Risk Assessments, and compliance-related documents
• Knowledge of ERES CFR Part 11 and GxP guidelines
• Skilled in IOQ protocol development, execution, and deviation management
• Experience verifying technical system drawings and documentation
• Proficient in developing Preventive Maintenance and Calibration forms and related training
• Strong background in SOP development and Cleanability Assessment
• Ability to prepare detailed Final Summary Reports
• Excellent organizational, communication, and problem-solving skills
• Flexibility to work extended hours, weekends, and holidays as needed

• Experience in pharmaceutical, biotech, or medical device industries
• Familiarity with computerized system validation (CSV) practices
• Certification in validation or quality assurance is a plus

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