Key Responsibilities:
Partner with local site automation, engineering, and quality assurance teams to plan, execute, and document automation changes and upgrades.
Support the full Software Development Life Cycle (SDLC) for automation systems, including design, development, testing, validation, and implementation.
Prepare, review, and approve automation-related documentation such as design specifications, validation protocols (IQ/OQ/PQ), RTM (Requirements Traceability Matrix), and change control records.
Participate in validation activities including protocol generation, execution, deviation handling, and final reporting.
Maintain inventory and control of automation hardware and software components, ensuring compliance with system lifecycle management policies.
Collaborate with project teams on commissioning and qualification of new PLC/SCADA systems and upgrades.
Support troubleshooting, corrective actions, and preventive maintenance on Siemens S7 PLCs and WinCC Unified SCADA systems.
Ensure all automation changes follow GxP, FDA, and internal Quality Management System (QMS) standards.
Provide input to continuous improvement initiatives related to automation, validation, and data integrity.
Core Technical Competencies:
Hands‑on experience with Siemens S7 PLC controllers (programming, configuration, troubleshooting).
Expertise in Siemens WinCC Unified HMI/SCADA systems.
Understanding of automation system validation (CSV), including IQ/OQ/PQ documentation and execution.
Knowledge of GAMP 5, GxP, and SDLC methodologies.
Experience in commissioning, qualification, and change control within regulated (pharma/life sciences) environments.
Familiarity with instrumentation, industrial networks (Profibus/Profinet), and integration to MES/LIMS systems (desirable).
Preferred / Desired Skills:
Prior experience working with Original Equipment Manufacturers (OEMs) on PLC/SCADA systems.
Exposure to WinCC Unified / TIA Portal environment.
Experience with validation planning and execution tools.
Excellent documentation, communication, and collaboration skills.
Strong analytical and problem‑solving mindset.
Qualifications:
Bachelor’s Degree in Electrical, Automation, Mechatronics, Computer, or Control Engineering (or equivalent).
Minimum 3–6 years of experience in automation engineering, PLC/SCADA systems, or control systems validation.
Certifications in Siemens PLCs or Automation Validation (CSV) preferred.
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