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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