CSV Engineer
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Location | Ireland |
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Job Type | Contract |
Blackfield Associates are working with a long standing client to provide a CSV resource in Ireland.
Requirements
Key Responsibilities
Plan and execute computer system validation activities throughout the system lifecycle.
Develop and maintain validation documentation, including:
Validation Plans (VP)
User Requirements Specifications (URS)
Functional Specifications (FS)
Design Specifications (DS)
Risk Assessments
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Traceability Matrices
Validation Summary Reports (VSR)
Collaborate with IT, Automation, Engineering, Manufacturing, Laboratory, and Quality teams to ensure validated state is maintained.
Support internal, customer, and regulatory audits by providing validation documentation and technical expertise.
Assist with software and infrastructure qualification activities, including cloud-based and SaaS applications where applicable.
Maintain validation schedules and ensure timely completion of deliverables.
Provide guidance and training to system owners regarding validation requirements.
Required Qualifications
Bachelor’s degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related discipline.
3–5+ years of experience in Computer System Validation within a regulated industry such as pharmaceutical, biotechnology, medical device, or healthcare.
Strong understanding of:
GAMP 5
FDA 21 CFR Part 11
EU Annex 11
Good Documentation Practices (GDP)
Data Integrity principles (ALCOA+)