KLEVA Pharmaceuticals S.A. is a privately owned pharmaceutical and fully integrated company that has been in operation in Greece for over 50 years. Kleva develops and manufactures generic products and focuses on Pharmaceuticals (Rx & OTC).

Our two manufacturing facilities in the North of Athens, Greece, are equipped with high technology machinery and have the manufacturing potential for a wide range of pharmaceutical forms.

Our mission is to offer a flexible, fully scalable, qualitative, and cost-effective product development in a wide range of dosage forms. We register and export our products to a number of regulated and non-regulated markets around the world.

To realize our ambitious goals, KLEVA needs people who are innovators, believe in the values of respect and cooperation and are ready to commit to a company that wants to penetrate new markets, leverage international business development opportunities, and enter contract manufacturing deals.

How you will support our mission: We are looking for an Automation Engineer.

Key Responsibilities:

    1. Automation System Development & Maintenance:

• Design, implement, and validate automated control systems (PLC, SCADA, DCS).
• Maintain and troubleshoot automation systems to ensure optimal performance.
• Develop HMI (Human-Machine Interface) and control logic for manufacturing processes.

      2. Regulatory Compliance & Validation:

• Ensure compliance with cGMP, FDA 21 CFR Part 11, GAMP 5, and other regulatory guidelines.
• Perform system validation, including IQ, OQ, and PQ for automated equipment.
• Maintain documentation for automation systems in compliance with regulatory standards.

     3. Process Optimization & Continuous Improvement:

• Implement automation solutions to improve efficiency, reduce downtime, and enhance product quality.
• Conduct root cause analysis (RCA) and corrective actions for automation-related deviations.

    4. Cross-functional Collaboration:

• Work closely with process engineers, quality assurance, IT, and manufacturing teams.
• Coordinate with vendors for automation system upgrades and troubleshooting.
• Provide training and technical support to operators and maintenance personnel.

Technical Skills:

• Experience with PLC and SCADA/DCS systems.
• Knowledge of industrial networking protocols (Profibus, Ethernet/IP, Modbus).
• Understanding of cGMP, GAMP 5, 21 CFR Part 11, and pharmaceutical validation requirements.
• Experience in MES (Manufacturing Execution Systems) and data integrity principles.
• Programming experience in Python, SQL, C++, VBA, or scripting for automation.

Soft Skills:

• Strong analytical and problem-solving abilities.
• Ability to work in a regulated environment with strict compliance requirements.
• Good communication skills for cross-department collaboration