Senior Automation Engineer

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Senior Automation Engineer will be responsible for supporting automation system design, implementation, commissioning, qualification, troubleshooting, and lifecycle management within a GMP-regulated pharmaceutical or biotechnology manufacturing environment.

The role requires strong hands-on experience with automation platforms, control systems, equipment integration, and GMP documentation. The Senior Automation Engineer will work closely with Manufacturing, Engineering, CQV, QA, IT/OT, vendors, and project teams to ensure automation systems are compliant, reliable, and fit for operational use.

Key Responsibilities

Automation System Support

• Support the design, configuration, testing, commissioning, and qualification of automation and control systems.
• Provide technical support for PLC, SCADA, DCS, HMI, BMS, EMS, and other automation-related systems.
• Troubleshoot automation issues related to equipment, process control, communication, alarms, interlocks, recipes, and system interfaces.
• Support automation system changes, upgrades, patches, and enhancements.
• Ensure automation systems are maintained in a validated and inspection-ready state.

Project & Commissioning Support* Support automation activities for new equipment installation, facility expansion, system upgrades, and process improvement projects.

• Review automation design documents, functional specifications, control narratives, P&IDs, wiring diagrams, I/O lists, and system architecture diagrams.
• Participate in FAT, SAT, commissioning, loop checks, I/O verification, alarm testing, sequence testing, and functional testing.
• Coordinate with equipment vendors and system integrators to ensure automation deliverables meet project, technical, and GMP requirements.
• Support system handover from project phase to routine operations.

Validation & Compliance

• Support or prepare automation-related validation documentation, including URS, FDS, HDS, SDS, risk assessments, test protocols, traceability matrices, and validation reports.
• Execute or support IQ, OQ, PQ, CSV, and automation qualification activities.
• Ensure compliance with GMP, GAMP 5, 21 CFR Part 11, EU Annex 11, data integrity, and site quality requirements.
• Support deviation investigation, CAPA, change control, periodic review, and audit readiness activities related to automation systems.
• Ensure automation changes are properly assessed, documented, tested, and approved before implementation.

System Lifecycle Management

• Support lifecycle management of automation systems from design, implementation, validation, operation, maintenance, and retirement.
• Maintain automation system documentation, backup records, access control, user management, and configuration records.
• Support system periodic reviews, disaster recovery checks, backup and restoration testing, and audit trail review where applicable.
• Identify opportunities to improve system reliability, reduce downtime, and enhance operational efficiency.
• Provide technical guidance to junior engineers or technicians where required.

Cross-Functional Collaboration

• Work closely with Manufacturing, Engineering, Maintenance, QA, QC, IT/OT, CQV, and external vendors.
• Support manufacturing operations during troubleshooting, process start\