Senior Validation Engineer – Limerick | Collins McNicholas

Senior Validation Engineer – Limerick

  • 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.

Responsibilities:

  • 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)

 

Requirements:

  • 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 kaylie.obrien@collinsmcnicholas.ie

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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Kaylie O'Brien

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  • Kaylie O'Brien
  • Recruitment Consultant
  • 021 4911064
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