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CSV / C&Q Lead – GxP at Advanced Manufacturing Tech Solutions (AMTSOL)

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

06 May, 26

Salary

0.0

Posted On

05 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CSV, C&Q, GxP, Computer System Validation, Commissioning, Qualification, Pharmaceutical Manufacturing, Automation Platforms, DeltaV, PLC, SCADA, BAS/HMI, GAMP 5, SDLC, Data Integrity, Validation Best Practices, Stakeholder Management

Industry

Pharmaceutical Manufacturing

Description

We are seeking a Senior CSV / C&Q Lead with deep expertise in GxP Computer System Validation and Commissioning & Qualification across pharmaceutical manufacturing environments. The role requires strong hands-on experience across the full CSV and C&Q lifecycle, leadership in regulated automation programs, and the ability to partner effectively with Quality, Engineering, IT, and Operations teams. Lead and execute end-to-end CSV and C&Q activities across the full lifecycle: URS Risk Assessment IQ / OQ / PQ UAT System Release Retirement Define and review validation strategies, plans, and execution models aligned with GxP and regulatory expectations. Ensure robust risk-based validation approaches in line with GAMP 5 principles. Required Qualifications & Experience Bachelors 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 (DeltaV, PLC, SCADA, BAS/HMI). Strong command of GxP regulations, GAMP 5, SDLC, data integrity, and validation best practices. Hands-on experience with Kneat Gx and structured validation documentation. Excellent stakeholder management and leadership skills.

Responsibilities

Lead and execute end-to-end CSV and C&Q activities across the full lifecycle. Define and review validation strategies, plans, and execution models aligned with GxP and regulatory expectations.