The Validation Specialist will support manufacturing by ensuring all aspects of validation such as equipment and facilities qualification, routine re-qualification activities, cleaning validation, computerized systems validation and process validation are complete and up to date and in line with required standards.
- Maintain the validation schedule and keeping all equipment and processes in a qualified state to support certification standards.
- Preparation and execution of validation protocols.
- Assist system owners with impact assessments and identifying qualification/validation requirements.
- Supervise all validation activities on equipment before handover/return to system owner and updating all relevant records and schedules.
- Supervise technicians, fitters and contractors as required when external support is utilized for qualification activities.
- Maintain validation equipment in a state of calibration and compliance to support the company’s validation efforts.
- Represent the business in customer audits and regulatory inspections to demonstrate that we have compliant systems.
- Create/maintain qualification related records, procedures, documents and drawings.
- Ensuring compliance with health and safety (EHS) legislation.
- Engaging with project teams to help with selection, installation and commissioning of new equipment.
- Validation experience within a GMP environment.
- Demonstrable validation experience in a medical device ISO13485, biopharmaceutical, consumer healthcare or related industry.
- Demonstrated understanding of validation requirements for international markets including (but not limited to) FDA and EMA.
- Knowledge of commissioning and equipment validation to include autoclaves, temperature controlled storage and automated production lines, cleaning validation experience.
- Proven problem solving skills/diagnosing faults/resolving qualification issues.
- Excellent planning and time management skills.
- The ability to adapt to rapid changes in project priorities and meeting aggressive timelines
- The ability to work independently and autonomously to support validation projects and communicate progress and any issues via team meetings and project meetings.