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.