全职 Computer Systems Engineer 工作, 薪水, Coalesce Management Consulting 公司招聘中 - Ricebowl

About the Company

Our client is a leading global healthcare and biopharmaceutical organisation with more than 125 years of industry heritage. Operating across approximately 140 countries with over 69,000 employees, the company is committed to providing patients and customers with a reliable supply of high-quality, safe and effective medicines and vaccines.

Its global supply strategy is supported by extensive manufacturing capabilities, technical expertise and a strong commitment to quality, compliance and operational excellence.

Role Overview

The Automation & Computer System Validation Engineer will support the lifecycle management, commissioning, qualification and validation of automated equipment and computerised systems within a GMP-regulated pharmaceutical manufacturing environment.

The role will work closely with Engineering, Automation, Quality Assurance, Validation, Manufacturing, project contractors and equipment vendors to ensure systems are appropriately specified, tested, qualified and maintained in a validated state throughout their lifecycle.

Key Responsibilities

• Support the complete lifecycle of computerised and automated systems, from initial design and installation through commissioning, qualification, operation, change management and retirement.
• Develop, review and maintain Computer System Validation strategies and equipment or system specifications.
• Prepare and execute commissioning and qualification documentation, including:
• Validation plans
• User Requirement Specifications
• Risk assessments
• Commissioning protocols
• Installation Qualification protocols
• Operational Qualification protocols
• Performance Qualification protocols
• Requirements Traceability Matrices
• Validation summary reports
• System-retirement plans and protocols
• Execute Computer System Validation activities in accordance with the System Development Life Cycle and applicable site procedures.
• Perform qualification and validation testing for pharmaceutical equipment, automated systems and associated software.
• Ensure validation activities comply with Good Engineering Practice, GAMP principles, GMP requirements, approved SOPs and relevant industry guidance.
• Review automated-system functionality, control strategies, alarms, interlocks, user access, audit trails, electronic records, data retention, backup and recovery controls, where applicable.
• Assess proposed changes to GMP equipment, automated systems, software, configurations and operating methods.
• Determine validation impact and establish the appropriate qualification or revalidation strategy required to maintain the validated state.
• Prepare clear test methodologies, test scripts, technical assessments and reports for automated systems.
• Review validation protocols, executed test records, discrepancies and summary reports for completeness, accuracy and compliance.
• Identify, document and investigate test failures, protocol deviations, system defects and qualification discrepancies.
• Coordinate resolution, corrective actions, retesting and closure of validation issues.
• Author, review and revise controlled documentation, including SOPs, validation master plans, qualification guidelines, execution plans and lifecycle procedures.
• Coordinate C&Q activities with project contractors, system integrators, equipment vendors and internal stakeholders.
• Track qualification progress against the project schedule and communicate risks, delays or technical issues to the project team.
• Support FAT, SAT, commissioning, system start-up, operational handover and inspection-readiness activities.
• Maintain complete, traceable and inspection-ready validation records throughout the system lifecycle.

Candidate Requirements

• Bachelor’s degree in Automation, Electrical or Electronic Engineering, Computer Engineering, Information Technology, Pharmaceutical Engineering or a related discipline.
• At least one year of relevant experience in automation, Computer System Validation, commissioning or equipment qualification.
• Experience working within the pharmaceutical, biotechnology or another GMP-regulated manufacturing environment.
• Practical experience with automation platforms such as Siemens or Rockwell PLC and HMI systems.
• Experience validating equipment or systems controlled by PLCs or distributed control systems.
• Understanding of Computer System Validation, the System Development Life Cycle and risk-based validation principles.
• Familiarity with qualification lifecycle documentation, including URS, risk assessments, IQ, OQ, PQ, traceability matrices and validation reports.
• Good understanding of GMP, Good Documentation Practices, data integrity and change-control requirements.
• Experience with technical writing, test-script preparation, protocol execution and validation-report generation.
• Strong understanding of software testing, QA methodologies and defect-management processes.
• Able to interpret technical specifications, control narratives, P&IDs, functional descriptions and system-design documents.
• Strong communication, organisation, troubleshooting and stakeholder-management skills.

Preferred Experience

• Experience with Building Automation Systems or Building Management Systems.
• Exposure to Emerson DeltaV or other distributed control-system platforms.
• Familiarity with GAMP 5, 21 CFR Part 11 or EU GMP Annex 11.
• Experience supporting automation-system upgrades, migrations, integrations or retirement projects.
• Previous involvement in FAT, SAT, commissioning and qualification of pharmaceutical manufacturing equipment.