Job Description

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.