EQUIPMENT VALIDATION ENGINEER

Anter Consulting Pte. Ltd.; Singapore; On-site; SGD 70,000 - 95,000; Full time

Job summary

Anter Consulting Pte. Ltd. is seeking an experienced Equipment Validation Engineer to support equipment qualification and CSV for a Repligen KrosFlo TFF system in a GMP-regulated biologics facility.

You will author and execute IQ/OQ/PQ protocols, verify installations, and lead CSV activities across HMI/PLC systems. The role requires 3–5 years in equipment qualification and CSV within GMP biopharma, with a degree in biotech or life sciences.

Qualifications

• 3–5 years' hands-on experience in equipment qualification (IQ/OQ/PQ) and computer system validation (CSV) within GMP-regulated biopharmaceutical manufacturing.
• 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.

Responsibilities

• Author and execute IQ, OQ and PQ protocols for a Repligen KrosFlo 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, TMP control and temperature control, and verify safety interlocks and alarms.
• Support membrane integrity testing and process performance runs demonstrating consistent flux, concentration and diafiltration performance.
• Lead or support CSV of the automation/control system (HMI/PLC, recipe management, data historian), including URS/FS/DS review, GAMP 5 categorization, 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 FAT and 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.

Skills

Equipment qualification

CSV

GAMP5

Technical writing

Education

Biotech/Life sciences degree

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.