CSV Specialist
CSV Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
We are seeking a skilled Computer System Validation (CSV) Specialist to support a fully onsite project with one of our key clients. The ideal candidate will have strong experience in validating GxPregulated systems ensuring compliance with 21 CFR Part 11 EU Annex 11 and applicable FDA and international regulations.
Responsibilities:
Develop review and execute validation deliverables including Validation Plans User Requirements Specifications (URS) Functional Specifications (FS) Risk Assessments Traceability Matrices Test Protocols (IQ/OQ/PQ) and Summary Reports.
Ensure systems are validated in accordance with client and regulatory requirements.
Support change control processes and manage deviations and CAPAs related to computer systems.
Collaborate with QA IT and business stakeholders to gather requirements and maintain validation documentation.
Conduct periodic reviews and revalidations as needed.
Participate in audits and inspections providing validation documentation as required.
Requirements:
Bachelors degree in Engineering Computer Science Life Sciences or related field.
3 years of handson CSV experience in regulated industries (pharmaceutical biotechnology or medical device preferred).
Strong knowledge of GAMP 5 21 CFR Part 11 EU Annex 11 and data integrity principles.
Experience with validation of software systems such as MES Data Historian ERP or SCADA preferred.
Excellent written and verbal communication skills.
Ability to work independently and onsite at client facilities.
Preferred Qualifications:
Experience working in a highly regulated environment.
Familiarity with validation in cloudbased and hybrid system environments.
Knowledge of SDLC and riskbased validation approaches.
Required Experience:
Unclear Seniority
Employment Type
Contract
