- Reference: CJ43616
- Job Type: Permanent
- Location: Limerick, Munster
- Category: Engineering, Technical & Manufacturing
Description: As the Senior Validation Engineer you will be working to ensure conformance to quality systems, to liaise with various departments, and give guidance, review documentation and ensure the company validation policies & procedures are being adhered to.
- Contributing to the preparation and review of the Validation Master Plan
- Generation of all validation strategies and deliverables
- Development and maintenance of internal validation policies and procedures based on best international standards and practices
- Auditing of internal projects against internal validation policies and procedures
- Managing the preparation, review and issuing of validation protocols and reports
- Generating validation documentation including risk assessments, traceability matrices, and validation reports.
- Reviewing and approving specifications associated with Equipment, Processes, Products and Computerised Systems.
- Establishing, implementing and directing validation and revalidation activities.
- Working directly with a cross functional team to define inputs and requirements to the MVP.
- Reviewing and managing change control forms for Validation/Compliance implications.
- Conducting routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.
- Updating existing quality documentation related to validation activities.
- Generating Standard Operating Procedures (SOP’s)
- Identifying training requirements in support of validation.
- Conducting Risk Assessments.
- Developing and reviewing software validation plans, test protocols, test data and test reports for embedded medical device.
- Execute test cases per protocol and document the results.
- Participate in the development and review of software requirements.
- Contribute to the design and implementation of software validation processes on projects.
- Work closely with software engineering team to ensure implementation and application of software validation principles throughout the development process.
- Provide technical direction and hands-on assistance for testing projects.
- Reviewing vendor validation documentation
- Co-ordinating the validation activities (including the vendors)
- Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline.
- Over 5 years’ experience as a Validation Engineer (mainly computer validation) in the Pharmaceutical or related Healthcare industry
- Experience of GxP Computerised Systems
- Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements.
- Familiar with the GAMP5 guidelines.
- Experience with serialization
- Experience with Systech Technology
- Excellent communication skills, including ability to advise and influence
- Excellent attention to detail
- Excellent understanding of validation concepts and documentation.
- Excellent communication skills, including ability to advise and influence.
- Should be based within a commutable range or else willing to re-locate for 1 year period
- Expected to be on site during the project with the exception of attendance at any FAT
For a confidential discussion and more information on the role, please contact Kaylie on 021 4911064 or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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