Validation Engineer
Validation Engineer
Posted on :
30-08-2025
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1 Vacancy
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Job Description
Responsibilities:
- Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance.
- Develop plans and reports such as validation plans/reports test plans/reports (and other deliverables).
- Update existing validation deliverables and procedures in collaboration with the system owners.
- Apply ALCOA principles to validation deliverables and quality management system records.
- Support in deviation investigations to identify root causes and define corrective and/or preventative actions.
- Support system audit/inspection preparation and execution as CSV subject matter expert.
- Complete or orchestrate timely completion of post-audit action items.
- Support system maintenance and enhancement activities ensuring the validated state is kept and it is audit and inspection ready.
- Support system periodic reviews according to company procedures.
- Collaborate with local and global stakeholders in defining and completing validation and compliance activities.
- Requirements:
- Education Bachelor of Science or equivalent in computer science engineering life sciences or related field.
- Minimum 6 years experience in IT OT or Software Technical Writing Quality Systems and Validation (CSV/CSA GAMP) preferably in a regulated industry.
- Good understanding of the ISA-95 models. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus.
- Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11 Annex 11 EU GMP Annex 1 GxP practices) and Data Integrity principles.
- Good understanding of system and data risk assessment concepts.
Employment Type
Full-time
Key Skills
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