CSV Lead GxP Validation

Matrix Process Automation Pte Ltd; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

A leading automation solutions provider in Singapore seeks an experienced CSV Lead responsible for managing validation activities within pharmaceutical environments. The ideal candidate will have over 10 years of experience, strong expertise in GxP regulations, and a proven track record validating automation systems like DeltaV and PLC. This role involves leading CSV strategies and ensuring compliance with global regulatory requirements while collaborating with various internal teams.

Qualifications

• 10+ years of experience in CSV, C&Q, and GxP system validation within pharmaceutical environments.
• 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.

Responsibilities

• Lead and manage end-to-end CSV and C&Q lifecycle activities.
• Define CSV strategies, validation plans, and execution models.
• Ensure compliance with FDA, EMA, and global regulatory requirements.

Skills

GxP regulations

CSV

C&Q

DeltaV

PLC and SCADA systems

Data integrity

Kneat Gx

Job description

• Weare seeking an experienced CSV Lead with strong expertise in GxP Computer System Validation (CSV) and Commissioning & Qualification (C&Q) within pharmaceutical manufacturing environments. The ideal candidate will lead CSV activities across regulated automation systems, provide validation governance, and work closely with Quality, Engineering, IT, and Operations teams to ensure compliant project delivery
• 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.

• 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