Role
CSV Engineer
Responsibilities
- Serve as an SME in CSV processes and best practices
- Develop and execute validation protocols (IQ/OQ/PQ) for computer systems, software applications, and automated processes.
- Create validation plans, test scripts, and summary reports.
- Ensure all computer systems comply with FDA regulations, GxP guidelines, and other relevant industry standards (e.g., 21 CFR Part 11).
- Provide training to staff on CSV processes and regulatory requirements
- Stay updated on industry best practices, regulatory changes, and advancements in technology related to CSV.
- Identify opportunities for improving validation processes and procedures.
- Perform Change Impact Assessments, Risk Assessments, Periodic Reviews .
NOTE: Experience in Validation of Enterprise IT Systems is a MUST.
Preferred candidate profile
- 2-5 years of overall experience in computer system validation within the pharmaceutical, biotech, or medical device industry.
- Experience with validation of IT Systems( Clinical Trial Management Systems, Regulatory Submission Systems, Drug Safety Systems, ERP systems, LIMS, MES, QMS, DMS, LMS or other GxP systems)
- Strong knowledge of FDA regulations, GxP guidelines, and industry standards (e.g., 21 CFR Part 11, GAMP 5).
- Proficiency in developing and executing validation protocols and related documentation.
- Proficient in using validation tools and software.
- Strong written and verbal communication skills.
Education and Trainings
- Bachelors degree in Biotechnology, Pharmacy, Computer Science, Engineering, Life Sciences, or a related field.
- Advanced degrees or certifications in validation, quality assurance, or regulatory compliance are a plus.