Job Description

Hemofarm is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans. Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.

Automation and Computerized Systems Validation (CSV) Engineer
Place of work: Vršac

About the job: As an Automation and CSV Engineer, you would be responsible for the operation and maintenance of automated systems, as well as for the implementation and maintenance of validation compliance of computerized systems within Hemofarm’s Technical Operations. This includes supporting the daily activities of the production site and the engineering department, providing engineering support to capital projects that will improve plant capacity, equipment reliability and operational efficiency, as well as performing GMP/CSV and data integrity activities at the site. In this position, you would act as the first point of contact and subject matter expert (SME) for the assigned automation systems and related areas within the supported business function.

Responsibilities:

• Responsibility for automated systems, including investigation of deviations and/or trend analysis based on data available in the automation system, including continuous improvements of automation in order to increase the efficiency and reliability of systems and processes
• Management of external contractors who provide engineering support for modification and maintenance of automation systems, infrastructure and equipment, in order to ensure optimal operation and reliability of the plant, as well as for capital and operational projects
• Support for implementation, maintenance and troubleshooting of Digital Factory Systems (real-time monitoring, OEE, downtime analysis), and Manufacturing Execution Systems (MES) integrated with shopfloor automation systems and enterprise applications
• Participation in maintaining the Unified Namespace (UNS) architecture for integration and contextualization of production data in real time
• Support for IT/OT integration projects – PLC, SCADA, Historian, Digital Factory, MES and Machine Data Connection (MDC), as well as support in the implementation of industrial communication protocols such as OPC UA and MQTT
• Ensuring secure and reliable data flow between automation and enterprise systems in accordance with GMP and Data Integrity requirements. Participation in OT cybersecurity and backup/recovery activities related to industrial automation and computerized systems
• Ensuring compliance with Annex 11, 21 CFR Part 11 and Data Integrity requirements for computerized systems and electronic records
• Responsibility for procedures relevant to processes in the lifecycle of computerized systems, development of test protocols, definition of test parameters for testing computerized systems, as well as support in creating CSV documentation, including URS, FS, DS, RA, TM, IQ/OQ/PQ protocols and validation reports.
• Administration of computerized systems through performing backup and restore activities, review of audit trail records, monitoring of user logins, data changes and other activities relevant for data integrity.
• Monitoring of GMP status and performance of assigned computerized systems and cooperation with QA, IT, Engineering teams and external suppliers.
• Maintaining business continuity and system recovery after an incident (Business Continuity and Disaster Recovery), including verification of data availability and integrity.
• Participation and presentation of topics from the area of computerized systems during internal, external and regulatory inspections and audits.

Qualifications:

• University degree in automation, electronics, mechatronics or a related technical field.
• Experience with automated systems (preferably in the pharmaceutical industry) and knowledge of cGMP and relevant regulatory requirements.
• Conversational knowledge of English language (minimum B2 level).
• Preferably knowledge of programming and ISA‑95 levels 1–3 (PLC, HMI, SCADA), ERP systems, and qualification/validation of facilities, utilities, equipment or related areas in pharma.
• Knowledge of CSV requirements, GAMP 5 and lifecycle methodology; experience with FAT, SAT, commissioning, validation of automation systems and understanding of P&ID, network architecture and automation project documentation is an advantage, as well as experience with UNS, industrial data models, MQTT, OPC UA, Modbus TCP/IP, Profinet, Ethernet/IP, SCADA, Historian, data collection systems, IT/OT integration, interface validation and OT cybersecurity principles.
• Strong analytical and problem‑solving skills, creativity, teamwork orientation and customer focus.

We offer:

• Private healthcare insurance (with the option of privileged usage for family members)
• Ongoing professional development through specialized education and training
• A platform for learning 14 foreign languages, using various learning styles, including conversation courses
• Personalized mental health and well-being support for employees and their families through the Kyan Health app.

Only shortlisted candidates will be contacted.