AIS Engineer (PLC)

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.