Commissioning & Qualification (C&Q) Specialist (North Region)
Synerlution, Inc
- Vega Baja, PR
- Permanent
- Full-time
- 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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