EQUIPMENT VALIDATION ENGINEER
We are seeking an experienced Equipment Validation Engineer to support equipment qualification and computer system validation (CSV) for a Repligen KrosFlo tangential flow filtration (TFF) system within a GMP-regulated biologics manufacturing facility. This role covers protocol authoring and execution, process performance verification, and validation of the associated automation and control system.
Key Responsibilities
- Author and execute Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols for a Repligen KrosFlo tangential flow filtration (TFF) system.
- Verify installation against approved P&IDs, vendor specifications and utility requirements (WFI, compressed air, electrical, drainage).
- Execute functional testing of pumps, pressure transducers, flow meters, transmembrane pressure (TMP) control and temperature control (where applicable), and verify safety interlocks and alarms.
- Support membrane integrity testing (e.g. diffusion or bubble-point testing) and process performance runs demonstrating consistent flux, concentration and diafiltration performance.
- Lead or support computer system validation (CSV) of the associated automation/control system (HMI/PLC, recipe management, data historian), including URS/FS/DS review, GAMP 5 categorization, and IQ/OQ/PQ test script execution.
- Assess and document 21 CFR Part 11 compliance — audit trail review, electronic signatures, user access controls and data integrity (ALCOA+).
- Coordinate Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) with the equipment vendor.
- Raise, investigate and close protocol deviations, and manage redlines through to final qualification reports.
- Prepare and maintain qualification documentation, traceability matrices and validation summary reports.
- Coordinate with Engineering, Automation, Quality and Manufacturing stakeholders throughout the qualification lifecycle.
Requirements
Experience & Knowledge: Minimum 3–5 years' hands-on experience in equipment qualification (IQ/OQ/PQ) and computer system validation (CSV) within a GMP-regulated biopharmaceutical manufacturing environment; Degree or diploma in Biotechnology, Chemical/Bioprocess Engineering, Life Sciences or a related technical discipline; working knowledge of tangential flow filtration (TFF) or comparable downstream bioprocessing skids is highly advantageous.
Technical Competencies: Practical experience authoring and executing IQ/OQ/PQ protocols; understanding of GAMP 5 software categorization and CSV lifecycle documentation (URS, FS, DS, traceability matrix); familiarity with 21 CFR Part 11 requirements (audit trails, e-signatures, data integrity); comfortable working with automation/control systems (HMI/PLC) and vendor documentation.
Soft Skills: Strong technical writing and documentation discipline; methodical, detail-oriented approach to protocol execution; effective communicator able to coordinate across Engineering, Automation, Quality and vendor teams.
Adaptability: Able to work onsite within a live GMP manufacturing environment and adjust to shifting qualification timelines and vendor schedules.