Computer System Validation (CSV) Engineer
Computer System Validation (CSV) Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Lead and execute CSV activities across GxP-regulated systems (LIMS MES ERP etc.
- Author and maintain validation deliverables: URS FS DS IQ OQ PQ and traceability matrices.
- Ensure systems comply with 21 CFR Part 11 EU Annex 11 and GAMP 5.
- Support system implementations upgrades and periodic reviews.
- Collaborate with QA IT and business users to drive validation strategy.
- Participate in audits and inspections to demonstrate compliance.
Requirements:
- Bachelors degree in computer science Engineering Life Sciences or related field.
- 2 years of hands-on CSV experience in pharma biotech or medical device environments.
- Strong working knowledge of GxP FDA regulations and SDLC methodologies.
- Experience validating cloud-based or SaaS GxP systems is a plus.
- Excellent documentation communication and collaboration skills.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
