EQUIPMENT VALIDATION ENGINEER

Roles & Responsibilities

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.

Tell employers what skills you have

Safety Checks
vendors requirements
Leadership
Operation Qualification
Factory Acceptance Testing
CSV files
Control & Automation
Electrical
Computerised Systems Validation
Installation Qualification
Process Flows
Data Integrity
Protocol Management
Flow Meters
Diffusion
Compressed Air