CSV Analytical and Enterprise Validation Specialist
CSV Analytical and Enterprise Validation Specialist
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1 Vacancy
Job Description
We are looking for a Validation Specialist IV who will lead validation and compliance activities for computerized systems analytical instruments and enterprise software. This includes supporting system implementation upgrades administration and retirement while ensuring compliance with regulations and internal procedures. The role works closely with Manufacturing Quality Engineering and IT teams.
Responsibilities:
- Lead validation efforts for new and existing systems.
- Act as the Subject Matter Expert (SME) for CSV analytical and enterprise systems.
- Review and approve qualification documents (IQ/OQ/PQ).
- Prepare user requirements and system configuration documents.
- Support data integrity assessments and audit trail reviews.
- Oversee equipment procurement and ensure proper installation and qualification.
- Perform system administration tasks (user setup backups troubleshooting).
- Write and update SOPs for system use and maintenance.
- Participate in risk assessments and change controls.
- compliance with 21 CFR Part 11 GAMP 5 and other regulatory guidelines.
- Bachelors degree in science or engineering field.
- 5 10 years of work in validation preferably in a pharma or biotech environment.
- Good understanding of CSV data integrity and GMP regulations.
- Experience with lab instruments and enterprise systems (like LIMS CDS ERP).
- Strong documentation and technical writing skills.
- Ability to troubleshoot and solve system-related issues.
- Comfortable working with different departments and vendors.
Employment Type
Full-time
