Are you interested in taking the next step in your career with a global leader in bio-technology and pharmaceuticals? Are you an experienced QA Validation Engineer for IT systems? Are you motivated by a new opportunity in a fast-paced environment? Don't hesitate, apply today!
Job Description
Our client in Limerick are seeking an experienced QA Validation Engineer to validate/qualify computer systems; including process automation systems, IS applications/infrastructure, and enterprise systems. You will plan, coordinate, and participate in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
Key Responsibilities
- Prepares/reviews validation documentation related to projects/change controls.
- Manages change controls and other compliance related tasks e.g. non-conformances.
- Participates in the review of current and future CSV procedures and polices
- Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
- Investigates and troubleshoots problems 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.
- 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.
- Manages projects and prepares status reports using Microsoft project and other communication tools.
Key Requirements
- Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.
- Experience in a GMP environment essential.
- Experience with validation of any of the following highly desirable; DeltaV, Maximo, etc.
Benefits
- Competitive and attractive employee compensation package
- Pension contributions
- Health insurance
- Paid public holidays
Location: Limerick, Ireland | onsite
