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À propos
Contract Type: Fixed-term / Daily Rate Contract
To be considered for an interview, please make sure your application is full in line with the job specs as found below.
Role Overview
We are seeking an experienced Computer System Validation (CSV) Engineer to support validation activities for GxP-regulated systems within a pharmaceutical/biotechnology/medical device environment. The successful candidate will be responsible for ensuring that computerized systems are validated in compliance with regulatory requirements and internal quality standards.
Key Responsibilities- Develop, review, and execute validation documentation including:
- User Requirements Specifications (URS)
- Functional Specifications (FS)
- IQ/OQ/PQ protocols and reports
- Ensure compliance with regulatory standards such as:
- EU GMP Annex 11
- FDA 21 CFR Part 11
- GAMP 5 guidelines
- Perform system risk assessments and define validation strategies based on system impact.
- Execute and/or coordinate validation testing activities (IQ, OQ, PQ).
- Support audits and inspections by regulatory bodies and internal QA.
- Collaborate with cross-functional teams (IT, QA, Engineering, Vendors).
- Review and approve system lifecycle documentation, including change controls and deviations.
- Ensure data integrity and compliance throughout system lifecycle.
- Provide guidance on CSV best practices and continuous improvement initiatives.
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
- 3+ years (mid-level) or 5+ years (senior) experience in CSV within a regulated environment.
- Strong knowledge of GxP systems validation and lifecycle management.
- Experience with:
- Manufacturing systems (e.g., MES, SCADA)
- Laboratory systems (e.g., LIMS)
- Familiarity with risk-based validation approaches (GAMP 5).
- Experience with audit/inspection readiness.
- Experience working on Irish or EU-based pharma/biotech sites.
- Knowledge of data integrity principles (ALCOA+).
- Exposure to cloud-based systems validation. xcfaprz
- Strong documentation and technical writing skills.
- Strong communication and stakeholder management
- Ability to work independently in a contract environment
- Problem-solving and analytical thinking
- Competitive daily rate (DOE)
- 6–12 month contract (with possible extension)
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Compétences linguistiques
- English
Avis aux utilisateurs
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