LEAD VALIDATION ENGINEER – CORK
Our Cork Partner is seeking a Lead Validation Engineer with emphasis on Quality Assurance. This role will ensure that qualification and validation activities supporting NPI, CSV and new equipment installation or approved third parties, comply with Company, Quality and regulatory requirements and expectations. The successful candidate will report to the Quality Director with key focus around customer specification, Validation Master Plan, protocols and reports.
- Provide technical and validation resource to manage the validation deliverables -linked to an Automation upgrade on site.
- Ability to coordinate the necessary activities for ensuring the timely closure of Validation activities on projects.
- Provide cross functional support for the quality and engineering groups, streamlining documentation and protocols procedures.
- Assisting Preparation, review and or approval with the development of validation documentation (plans, protocols, reports etc.)
- Support Validation activities in relation to equipment, facilities, utilities, automation, manufacturing and cleaning processes (FAT, SAT, IQ, OQ, PQ).
- Providing hands on support, guidance and direction to all areas of the organization including its third-party contractors.
- Review and approval of third party generated protocols and reports.
- Project Validation Master Plans generation.
- Generation and review/approval of deviations.
- CAPAs, change requests & SOP/Work instructions.
- Risk Assessments & System Impact Assessments.
- Supervisory experience and management of third-party providers
- Trending and tracking of Validation data to drive improvements e.g. Sampling data, project protocols and reports.
- Develop on site Quality and compliance in conjunction with the appropriate department, to ensure customer related problems/issues are communicated and corrective actions are in place and closed in a timely manner.
- 3 years of hands on experience in QA Validation, Equipment Qualification & Process Validations
- Pharmaceutical/ Biopharmaceutical experience under cGMP regulations
- Experience developing and improving manufacturing/production systems
- Knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential.
- B.S. , M.S. or MBA in Science, Biology, Chemistry, or Engineering.
- Demonstrated experience in a Lead capacity
- CSV knowledge is desirable
To find out more about this new opportunity please send your CV to firstname.lastname@example.org or for a confidential conversation call Barry Jones on +353 21-2363154