We are seeking an experienced CSV Engineer who will play a pivotal role in validating and maintaining computerized systems to meet regulatory requirements and adhere to industry best practices.
This is a 12 month hourly rate contract position.
Key Responsibilities:
- Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for various computer systems and software applications.
- Participate in change control processes, assessing the impact of system changes and overseeing appropriate validation activities.
- Work collaboratively with Quality Assurance, Operations and IT teams to ensure adherence to regulatory guidelines and internal policies.
- Conduct risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
- Create and maintain comprehensive validation documentation, including validation plans, test scripts, traceability matrices, and validation summary reports.
- Execute qualification of manufacturing automation systems (e.g., DeltaV, MES).
Education / Experience:
- Degree in Computer Science, Engineering, Life Sciences, or equivalent.
- 3+ years' CSV experience in a GMP-regulated pharmaceutical or biotech environment.
- Experience working with MES, and DeltaV/SCADA systems.
- In-depth knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and data integrity principles.
- Familiarity with SAP, TrackWise, or similar ERP/QMS platforms.
- Strong Communication skills
