LCM (Life Cycle Management) Engineer (Contract)

LCM (Life Cycle Management) Engineer
12 month contract

About the Company:
Our client is a US healthcare and a leading global biopharmaceutical company. They have a revenue of US $40.1 billion, with more than 69,000 employees across 140 countries with a heritage of more than 125 years. Our client is committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Their global supply strategy relies on manufacturing capabilities and expertise to achieve this mission.

Job descriptions:

• 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.
• Strong 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.

Job 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 preferred.
• Experience in the pharmaceutical industry

Reg No: R22104540
EA License no: 94C3609