ProClinical is currently seeking a CSV Engineer for a management consulting group that provides global compliance, remediation and project management services to the medical device, pharma and biotech industries. This is a contract role based in Limerick, Ireland.
- Analyses the results of testing and determines the acceptability of results against predetermined criteria.
- Investigates and troubleshoots problems with Rockwell Automation and Siemens automation control systems which occur and determines solutions or recommendations for changes and/or improvements.
- Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
- Ensure compliance with automation system coding standards such as S88 and ISA 95.
- Lead process improvement projects to improve the validation of computerized systems
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Participates in regulatory audits and communicates company's computer validation policies.
- Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps and ensure best data integrity practices are enforced.
- Trains /advises less experienced Specialists and Technicians.
- Possesses a thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211.
Skills and Requirements:
- Technical writing experience.
- Generation, Review and Approval of Validation documents.
- Strong attention to detail and accuracy.
- Experience in risk assessments in relation to validation activities.
- Advise and support all teams on computer validation activities.
- Excellent communicator.
- Project planning experience a distinct advantage
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Owen Bach on +44203 8261 330 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.