Job Title: CSV Engineer
About the Role
We are seeking a skilled CSV Engineer to join our organization on a 12-month contract. The successful candidate will be responsible for ensuring compliance of computer systems within a GMP-regulated environment.
Key Responsibilities:
* Validation Protocols: Develop and execute validation protocols (IQ, OQ, PQ) for computerized systems.
* Compliance: Ensure compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and other regulatory standards.
* Risk Assessments: Conduct risk assessments and impact analyses on computer systems.
* Documentation: Maintain validation documentation and support audits.
* Collaboration: Collaborate with cross-functional teams including Quality, IT, and Manufacturing.
* System Support: Support system upgrades, troubleshooting, and continuous improvement initiatives.
About You
To be successful in this role, you will need:
* Education: Bachelor's or Master's degree in Engineering, Computer Science, or a related field.
* Experience: 3+ years of experience in computer system validation within a pharmaceutical or biologics environment.
* Skills: Strong knowledge of GMP regulations, FDA 21 CFR Part 11, and data integrity principles.
* Software Knowledge: Experience with LIMS, MES, ERP, SCADA, and other automated systems is a plus.
* Personal Qualities: Excellent problem-solving, documentation, and communication skills.