Senior Automation Engineer

Key Accountabilities

Ethics & Compliance: Ensure personal and team alignment to internal policies, GMP requirements, and regulatory standards. Maintain required training and support audit readiness.

Financial & Project Management: Follow AZ financial policies and handle resource requests. Lead small capital projects using standard project management frameworks.

Leadership & Collaboration: Connect team members to broader site objectives and ensure alignment across groups. Understand system design end-to-end to support effective multi-functional work.

Continuous Improvement: Drive improvements to processes supporting Lokelma manufacturing and site operations.

Essential Functions

• Coordinate development, implementation, and support of site automation and SCADA systems (PLC/HMI, batch, historian, MES interfaces).
• Review and approve technical specifications, drawings, and code.
• Lead solving, root cause analysis, and corrective actions.
• Train others on systems and procedures.
• Develop and implement validation protocols and maintain SOPs.
• Monitor system performance and identify improvement opportunities.
• Coordinate third-party suppliers during system development, installation, and qualification.
• Provide on-call automation support.

Other Responsibilities

• Author and handle change records, deviations, CAPAs, and investigations.
• Support internal/external audits and interactions with regulatory agencies.
• Lead capital project execution within budget and timelines.
• Evaluate and specify new automation tools and equipment.
• Maintain documentation and ensure compliance with GMP, SOPs, and safety requirements.

Safety, Health & Environment: Promote a safe work environment and proactively address hazards.

Delivery & Support: Provide timely on-call support and collaborate with maintenance and metrology teams. Implement change controls to improve qualified systems.

Cost Management: Promote cost-conscious decision-making.

Lean & Standard Work: Ensure work follows established processes and standard procedures.

People Management: No direct reports; may provide project-based or matrix leadership.

Minimum Requirements

• Bachelor's Degree in Engineering, Computer Science, or related field
• Validated 4 years experience in one of the following: Industrial automation systems in a manufacturing environment, preferably pharmaceutical or regulated industry; OR Pharmaceutical/biologics process engineering or quality engineering with direct teamwork on automation and control systems
• Proven ability to fix or interpret control logic, batch sequences, or PLC programs
• Knowledge of process and utility development, operation and maintenance
• Detailed understanding of GMP related to facility development and operation
• Strong problem-solving skills

Desirable Qualifications

• Experience with Rockwell Automation control systems
• Experience in automation, SCADA systems, software development
• Comprehensive understanding of IT infrastructure as it relates to automated systems
• Detailed understanding of electrical schematics
• Understanding of instrumentation and maintenance of equipment applied in automated systems
• Lean Leadership principles and application in a GxP environment