Equipment/CSV Validation Specialist
Alcon
- Cork
- Permanent
- Full-time
- Coordinate lifecycle of Laboratory Assets, including change controls, calibration/qualification, maintenance and asset retirement.
- Support of analytical Test Methods (TM) life cycle as required.
- Support the Lab Inventory Management, including standards.
- Perform required equipment troubleshooting studies/investigations to resolve technical and/or operational issues, for process improvements and validations.
- Lead/Participate in internal and external audits.
- Comply and adhere to all the relevant company policies, industry standards and regulatory requirements.
- Adhere to laboratory dress code and facility safety procedures.
- Ensure continual Quality System compliance by adherence to established and evolving Alcon QS requirements.
- Third level qualification in Chemistry/Microbiology or technically related discipline
- 4 years’ experience in a Medical Device/Pharmaceutical Laboratory position with proven troubleshooting and validation experience
- Knowledge of FDA, medical device, GMP and validation requirements.
- Strong chemical/microbiology technical knowledge, with system troubleshooting and validation experience.
- Excellent attention to detail
- Technical understanding of chemical/microbiology processes
- A competitive salary package with fixed salary, bonus, pension, and health insurance
- A flexible work environment with competent and committed colleagues. We enjoy working together in a good and respectful manner, and we celebrate our common successes.
- See your career like never before with focused growth and development opportunities.