Computer System Validation (CSV) 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.
Responsibilities:
- Understand development of Computer System Validation (CSV) and equipment specifications and executing 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) 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.
- Expertise in evaluating validation protocols and summary reports.
- Strong understanding of Testing and Software Development Lifecycle and QA methodologies.
- Responsible for being a quality contact and primary Subject Matter Expert (SME) for complex deviations for systems, processes, and equipment related to engineering, facilities, automation, manufacturing, and validation.
- Support and review complex deviation investigations related to manufacturing process equipment, utilities, automation, validation, and engineering.
- Work closely with Operations, Facilities, Manufacturing, Automation, Validation, and Engineering to resolve open issues resulting from equipment failures, issues, and deviation record reviews.
- Lead the QA review and assessments of deviations; includes performing risk assessments, leading root cause analysis investigations, tracking, follow-up, close out, and reporting/trending.
Job requirements:
- Minimum 5 years of demonstrated experience in cGMP automation/computerized systems, quality, and compliance areas in the pharmaceutical industry.
- Thorough understanding of industry standards and best practices for computer system validation.
- Extensive experience with validation of equipment controlled by PLCs, BAS/BMS systems, and other typical automated system platforms preferred.
Reg No: R22104540
EA License no: 94C3609
