Computer System Validation (CSV) Lead

APBA TG Human Resource Pte Ltd; Singapore; On-site; SGD 80,000 - 110,000; Full time

Job summary

A recruitment agency in Singapore is seeking an experienced professional for CSV management in pharmaceutical environments. The role involves leading validation activities, ensuring compliance with GxP regulations, and managing cross-functional stakeholder engagement. Ideal candidates will possess a Bachelor’s degree and over 10 years of relevant experience in CSV and GxP validation. Strong communication and leadership skills are essential for success in this position, which offers a dynamic working environment.

Qualifications

• 10+ years of experience in CSV, C&Q, and GxP system validation within pharmaceutical or biopharma manufacturing.
• Proven experience validating automation platforms.
• Strong understanding of GxP regulations, GAMP 5, SDLC, and data integrity.

Responsibilities

• Lead end-to-end CSV and C&Q lifecycle activities.
• Define CSV strategies and validation plans.
• Ensure compliance with FDA and global regulatory requirements.
• Act as the CSV SME during audits and inspections.

Skills

CSV management

Risk-based validation

Stakeholder management

Compliance with GxP regulations

Communication skills

Education

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline

Tools

Kneat Gx

DeltaV

PLC

SCADA

BAS/HMI systems

Job description

Key Responsibilities:

• Lead and manage end-to-end CSV and C&Q lifecycle activities, including:
  URS → Risk Assessment → IQ / OQ / PQ → UAT → System Release → Retirement
• Define CSV strategies, validation plans, and execution models aligned with GAMP 5 and GxP regulations.
• Ensure adoption of risk-based validation approaches across automation and GxP systems.

• Lead validation for automation and control systems, including:
  • DeltaV DCS / Batch systems
  • PLC & SCADA systems
  • BAS / BMS / EMS / HMI systems
• Support validation of large GxP IT and digital manufacturing systems in pharma environments.
• Review and approve key validation deliverables such as URS, FRS, RTM, test protocols, deviations, and summary reports.

• Ensure compliance with FDA, EMA, and global regulatory requirements, including data integrity and ALCOA+ principles.
• Act as the CSV SME during audits, inspections, and quality reviews.
• Support change control, deviation management, periodic review, and system retirement activities.

• Hands‑on experience using Kneat Gx for validation authoring, execution, and traceability.
• Ensure strong documentation governance, traceability, and audit readiness throughout the system lifecycle.
• Apply SDLC best practices across validation and system changes.

• Engage with cross‑functional stakeholders including Quality, Automation, IT, Engineering, and external vendors.
• Provide technical guidance and oversight to CSV and validation engineers.
• Communicate risks, progress, and compliance status clearly to project and quality leadership.

Required Qualifications & Experience:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline.
• 10+ years of experience in CSV, C&Q, and GxP system validation within pharmaceutical or biopharma manufacturing.
• Proven experience validating automation platforms such as DeltaV, PLC, SCADA, and BAS/HMI systems.
• Strong understanding of GxP regulations, GAMP 5, SDLC, data integrity, and validation best practices.
• Hands‑on experience with Kneat Gx and structured validation documentation.
• Strong stakeholder management, leadership, and communication skills.

To Apply, please kindly email your updated resume to [e-mail]

Regret to inform that only shortlisted candidates will be notified.

CEI: R25127749

EA License: 14C7275