- Reference: GY43740
- Job Type: Permanent
- Location: Limerick
- Category: Science, Pharmaceutical & Food
The individual in this position implements policies and procedures to validate/qualify production automation/enterprise systems. Plans, coordinates, and participates in a compliant validation process for production automation/enterprise systems which requires formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
- Analyzes 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.
- 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.
Skills, Experience and Qualifiations:
- Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of automation, enterprise systems and biotechnology; will substitute relevant experience for education.
- Experience with process control systems or enterprise system deployment essential.
For a confidential discussion and more information on the role/company please email your CV to: firstname.lastname@example.org