Pharma Lifecycle Validation Engineer – CSV/Automation

Manpower Staffing Services (Singapore) Pte Ltd; Singapore; On-site; SGD 71,000 - 85,000; Full time

Job summary

Manpower Staffing Services (Singapore) Pte Ltd seeks a Pharma Life Cycle Management Engineer (CSV/Automation) for a 12-month contract at Tuas, Singapore. The role involves end-to-end lifecycle activities for computerized systems, CSV development, and validation planning in a pharmaceutical context.

The candidate will generate C&Q protocols, execute validation activities (IQ/OQ/PQ), and ensure cGMP compliance while coordinating with contractors and vendors to deliver tests on time.

Qualifications

• At least 1 year of experience in Automation, CSV/validation, and commissioning.
• Experience in automation such as Siemens/Rockwell PLC/HMI development.
• Familiarity with validation of equipment controlled by PLCs, BAS/BMS systems, DeltaV.
• Experience in the pharmaceutical industry.

Responsibilities

• Involvement in end-to-end life cycle phases of computerized systems from design, installation, qualification to retirement.
• Understand development of Computer System Validation (CSV) and equipment specifications.
• Generate C&Q Protocols and Retirement plans for projects.
• Execute CSV, SDLC, and related qualification activities (IQ/OQ/PQ) per cGMP, GAMP, SOPs and guidance documents.
• Assess impact of changes to cGMP equipment/systems and establish applicable Validation Plans.
• Prepare technical writing and reports for testing methodologies of automated systems.
• Evaluate validation protocols and summary reports.
• Write, review and revise Installation, Operation and Performance qualification/verification documents (SOPs, master plans, guidelines, execution plans).
• Deliver C&Q activities to meet schedule and track progress.
• Coordinate with project contractors and equipment vendors to execute required tests.

Tools

Siemens PLC

Rockwell PLC

HMI development

DeltaV

Job description

Manpower Staffing Services (Singapore) Pte Ltd seeks a Pharma Life Cycle Management Engineer (CSV/Automation) for a 12-month contract at Tuas, Singapore. The role involves end-to-end lifecycle activities for computerized systems, CSV development, and validation planning in a pharmaceutical context.

The candidate will generate C&Q protocols, execute validation activities (IQ/OQ/PQ), and ensure cGMP compliance while coordinating with contractors and vendors to deliver tests on time.