CSV Engineer (EPKS & TPS)

Responsibilities: Provides expertise in performing Computerized Systems Validation. Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations (GxP, 21CFR11, etc.) Perform collaborative work with the Compliance Engineering team on other CQV activities. Coordinate with both internal and external teams (manufacturing, engineering, quality, vendors, contractors, etc.) to achieve the site objectives. Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports) Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements. Investigate deviations and write deviation reports and findings. Raise and follow-up change control records. Requirements: Degree in Engineering/Science or related studies. Minimum of 4 years' experience in relevant industry with at least 8 years in CSV, Qua...