Find Computer system validation engineer Jobs

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AIS Engineer (PLC)

WuXi Biologics -
Dundalk, County Louth

Apply Now

Job details

7 days ago

Qualifications

System administration
Chemical Engineering
Computer Science
Engineering
Bachelor's degree
Electrical Engineering
Communication skills

Full job description

AIS Engineer (PLC)

The Automation Engineer is responsible for supporting, maintaining and improving automation systems across the site. The individual will provide technical expertise, ensure system reliability, develop automation strategies, support new technology introductions, and act as a system owner in accordance with GMP, site procedures and corporate standards.

Essential Duties and Responsibilities

System ownership and administration of assigned automation systems in a GMP environment
Execution and support of system improvements, change control, configuration updates and lifecycle management
Troubleshooting, technical root cause analysis and resolution of issues related to controls, instrumentation, networked automation, software and hardware
Development and review of URS, SDS, design documentation, specifications and SOPs as required
Support for new product introductions and engineering studies, including automation assessments and configuration changes
Ensure compliance with GAMP, applicable standards (e.g. ISA-88, S95), data integrity and 21 CFR Part 11 requirements
Maintain system reliability through preventive maintenance, patching, backups and disaster recovery processes
Support operational readiness and continuous improvement initiatives across automation platforms
Collaboration with manufacturing, engineering, utilities, quality, IT and external vendors
Perform duties in accordance with GMP, safety standards and site policies
Flexibility to take on additional responsibilities as assigned by the AIS Lead
Will act as a role model for the Engineering function and also the wider organisation in adherence to the
WuXi corporate core values and PROUD culture.

Technical Competencies

Strong understanding of industrial automation systems, control platforms and instrumentation
Ability to interpret automation documentation including P&IDs, network diagrams, design specifications and validation documents
Familiarity with automation lifecycle management, change control and validation principles
Knowledge of industry standards including GAMP, ISA-88/95, and data integrity requirements
Understanding of network fundamentals, cybersecurity principles and integration concepts
Ability to diagnose complex equipment, software and control issues

Experience

Experience in a pharmaceutical, biotechnology or regulated manufacturing environment
Hands-on experience supporting automation, control systems, equipment integrations, instrumentation or
Experience with troubleshooting, system administration, commissioning, qualification and change control

Knowledge

Knowledge of GMP operations and regulatory expectations for automated systems
Understanding of automated equipment, batch systems, utilities, networked assets, or virtualised environments (depending on sub-function)

Qualifications

Bachelor’s degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering or related technical discipline
3–5+ years relevant industry experience preferred
Behavioural Competencies
Independent, self-directed, well-organised and capable of managing multiple priorities
Strong communication, collaboration and stakeholder management skills
Problem-solving mindset with a focus on compliance, reliability and continuous improvement
Demonstrates integrity and adherence to procedures, standards and regulatory obligations

WuXi Biologics is an equal opportunities employer.

Apply Now

Refine Your Search

computer system validation engineer jobs

AIS Engineer (PLC)

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