CSV Specialist
CSV Specialist
Posted on :
22-07-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Responsibilities:
- Lead and manage computer system validation (CSV) projects including authoring and executing specifications and validation documentation for enterprise systems.
- Develop and author validation protocols ensuring compliance with 21 CFR Part 11 Annex 11 GxP and internal corporate policies.
- Perform reviews and remote execution of validation protocols in accordance with cGMP ISPE GAMP 5 and corporate standards.
- Ensure data integrity system security access control and user safety are adequately addressed within validation documentation.
- Conduct risk assessments and prepare validation summary reports aligned with GMP and regulatory requirements.
- Investigate and support resolution of Deviations CAPAs and other quality system activities including Periodic Reviews.
- Create comprehensive validation deliverables including plans specifications protocols traceability matrices and change controls.
- Validate software for manufacturing instruments while managing up to four concurrent validation projects.
- Waters/Empower/OSI PI/MODA/Unicorn/Process Pad or products serving the same function.
- Various Manufacturing Instruments Software.
- Other Enterprise Applications as Required.
- 7 years of experience in FDA-regulated industries with strong knowledge of GMP 21 CFR Part 11 and Annex 11.
- 5 years of experience in document authoring SOP revisions and protocol re-execution.
- Demonstrated ability to manage multiple concurrent validation or system implementation projects.
- Experience validating software for manufacturing instruments as well as enterprise systems such as SAP Empower and Veeva or similar.
- Proficient in both traditional (V-Model) and modern (CSA) validation approaches.
- Familiarity with Agile and Waterfall methodologies in system and software development environments.
- Excellent written and verbal communication skills; strong collaborator with cross-functional teams.
- Self-motivated adaptable and customer-focused with a proactive approach to leadership and problem-solving.
- BS/BA required in a related field.
- 5 years minimum required relevant experience.
Employment Type
Full-time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
