Website Karwell Technologies
Karwell Technologies
Company : Karwell Technologies
Job Description:
Support IT/OT system owners with computer system validation (CSV), lifecycle documentation, compliance reporting, and ongoing system maintenance for GMP-regulated manufacturing systems (ISA-95 Level 2 & 3).
Responsibilities:
- Perform CSV/CSA lifecycle activities: validation, testing, documentation, and periodic reviews.
- Create/update and execute validation protocols (IQ/OQ/PQ, test scripts, reports).
- Support annual system maintenance (MILE) and system audits.
- Manage QMS records (CAPA, Deviations, Planned Events).
- Ensure GMP & data integrity compliance during system upgrades/changes.
- Collaborate with system owners and global stakeholders.
- Support document management systems and compliance reporting.
Mandatory Skills / Requirements:
- Bachelor's degree in engineering, Computer Science, Life Sciences, or related field.
- 5+ years of CSV experience (GAMP / CSA) in Pharma or regulated industry.
- Strong experience with ISA-95 Level 2 & Level 3 systems.
- Hands-on knowledge of FDA 21 CFR Part 11, EU GMP, Annex 11, GxP & Data Integrity.
- Experience supporting IT/OT manufacturing systems validation and compliance
Preferred Skills:
- Experience with DeltaV, MES, SCADA, OSI-PI, Siemens Desigo, Rockwell FactoryTalk, Client.
- Experience with Veeva, Condor, eVal Roche or similar DMS tools.
- MES administration, EBR recipe authoring.
- Exposure to Level 1 systems.
- Strong compliance reporting and metrics experience.