Pharma Life Cycle Management Engineer (CSV/ Automation)

Manpower Singapore; 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

Pharma Life Cycle Management Engineer (CSV/ Automation)

12 months contract

Salary up to $7,000 depending on experience

Location : Tuas

Industry : Pharmaceutical

Our client is a leading U.S.-based biopharmaceutical company with over 125 years of history, operating in more than 140 countries and employing over 69,000 people worldwide. The company is dedicated to delivering high-quality medicines and vaccines through its great global manufacturing and supply network.

Responsibilities:

• Involvement in end-to-end life cycle phases of computerized systems from design, installation, qualification until retirement.
• Understand development of Computer System Validation (CSV) and equipment specifications.
• Generate Commissioning & Qualification (C&Q) Protocols and Retirement plans for projects.
• Execute Computer System Validation, System Development Life Cycle (SDLC), and other pharmaceutical equipment/system commissioning/validation such as installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), retirement plan protocols in accordance with Good Engineering Practices, GAMP, local SOPs, industry best practices and other industry related guidance documents.
• Assess the impact of changes to cGMP equipment/systems and methods and establish the applicable Validation Plan to ensure the validated status following changes.
• Experience in technical writing and report generation of testing methodologies of automated systems.
• Experience in evaluating validation protocols and summary reports.
• Good understanding of Testing and Software Development Lifecycle and QA methodologies.
• Writes, review and revise a variety of Installation, Operation and Performance qualification/verification related documents, including any of the following: SOPs, validation/verification master plans, guidelines and execution plans
• Deliver the C&Q activities as required to meet the schedule
• Track progress of C&Q activities as required.
• Coordinate with project contractors and equipment vendors to execute required tests.

Requirements:

• At least 1 years of experience in Automation, Computer System validation, qualification, and commissioning experience
• Experience in automation such as Siemens/Rockwell PLC/HMI development
• Experience with validation of equipment controlled by PLCs, BAS/BMS systems, DeltaV, and other typical automated system platforms
• Experience in the pharmaceutical industry