Job Scope:

Automation System Ownership

Act as the primary owner for plant automation systems (PLC, SCADA, MES, historians).
Ensure systems meet data integrity, cybersecurity, and regulatory standards.
Keep all automation platforms in a validated, compliant state in line with GAMP 5 and cGMP requirements.

Design & Implementation

Create and deploy automation solutions for both new and existing processes, including integration with digital manufacturing platforms.
Serve as SME and reviewer for URS, FS, SDS, HDS, and validation deliverables.
Participate in or lead FAT, SAT, and IQ/OQ/PQ qualification activities for automation projects.

Continuous Improvement & Digitalization

Lead Industry 4.0 efforts such as predictive maintenance, real-time analytics, and smart sensor technologies.
Use Lean and Six Sigma tools to streamline automated processes and minimize downtime.
Apply advanced process control methods and best practices in alarm management.

Project Management

Oversee automation projects from initial concept through implementation, managing budgets, timelines, and suppliers.
Deliver automation upgrades and expansions on schedule and aligned with operational priorities.

Technical Leadership & Training

Provide expert support and mentorship to operations and maintenance personnel.
Develop and deliver training programs focused on automation troubleshooting and system performance improvement.

Compliance & Governance

Ensure compliance with 21 CFR Part 11, GAMP 5, and cybersecurity requirements.
Support internal and external audits and regulatory inspections related to automation and metrology systems.

Requirements:

Experience in Automation System in Pharmaceutical or medical device industry
Experience in DI compliance, GAMP 5 validation, cybersecurity, SCADA, MES, historian systems, PLC

Multinational corporation

Attractive salary package

Production Manager

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