CSV Engineer

A global leader in animal health, developing and providing vaccines, medicines, diagnostics, and technologies for both livestock and companion animals.

• Lead the validation activities for Siemens PCS7 systems, including the authoring and execution of Validation Plans, User Requirement Specifications (URS), Functional Specifications (FS), and Design Specifications (DS).
• Draft, review, and execute IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols for PCS7-controlled equipment and software updates.
• Act as a Subject Matter Expert for Data Integrity (ALCOA+), ensuring that PCS7 audit trails, user access levels, and data storage systems meet strict regulatory requirements.
• Conduct System Impact Assessments and Quality Risk Assessments to identify critical system functionalities and mitigate risks related to patient safety and product quality.
• Manage technical change controls for automation upgrades and lead investigations into deviations or non-conformances related to computerised systems.
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) at vendor sites for new PCS7-based skid equipment.

• Bachelor's degree in Engineering (Automation, Electrical, or Chemical), Computer Science, or a related Life Sciences discipline.
• 3-5+ years of CSV experience in a GxP environment (Pharma/Med-Device).
• Demonstrated experience validating Siemens SIMATIC PCS7 systems, including familiarity with WinCC (SCADA), Step 7, and Batch operations. xcfaprz
• Deep understanding of GAMP 5 (Risk-based approach), 21 CFR Part 11, and EU Annex 11.
• Familiarity with PLC/DCS architectures, industrial networks (Profinet/Profibus), and historian systems (e.g. OSIsoft PI) is highly desirable.