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-up, shutdown, batch execution, and equipment recovery. • Communicate technical risks, project updates, system issues, and recommended actions clearly to stakeholders. • Participate in technical meetings, design reviews, project discussions, and inspection preparation. • Required Qualifications Education • Degree or Diploma in Automation Engineering, Electrical Engineering, Mechatronics, Computer Engineering, Chemical Engineering, or related discipline. Experience • Minimum 5 to 8 years of relevant automation engineering experience in pharmaceutical, biotechnology, medical device, chemical, or GMP-regulated manufacturing environment. • Hands-on experience with automation systems such as PLC, SCADA, DCS, HMI, BMS, EMS, or MES interfaces. • Experience supporting automation activities during project execution, commissioning, qualification, and routine operations. • Experience with GMP documentation, change control, deviation investigation, and validation support. Technical Skills • Strong knowledge of automation platforms such as Siemens, Rockwell/Allen-Bradley, DeltaV, Wonderware, iFIX, GE, Schneider, Emerson, or equivalent systems. • Familiar with PLC logic, control sequences, alarm management, recipe management, batch control, and equipment interfaces. • Able to read and interpret P&IDs, control narratives, electrical drawings, loop diagrams, I/O lists, and system architecture documents. • Good understanding of GAMP 5, CSV, data integrity, 21 CFR Part 11, and EU Annex 11 requirements. • Experience with automation system backup, restoration, access management, audit trails, and lifecycle documentation. • Knowledge of OT network, industrial communication protocols, and cybersecurity principles will be advantageous. Soft Skills • Strong troubleshooting, analytical, and problem-solving skills. • Able to work independently and provide technical guidance to others. • Good communication and stakeholder management skills. • Detail-oriented with strong GMP documentation discipline. • Able to manage multiple priorities in a fast-paced project or manufacturing environment. Why join us? • Generous Leave Policy. • Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs. • Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company. • Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated. • Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career. How to apply Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team! Please submit your resume, outlining your qualifications and experience relevant to the role, here.