Engineer (Automation/Pharma/Medical Device)

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