PDAP - Senior Automation Systems Engineer

About SHL Medical

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

As a
Senior Automation Systems Engineer,
this role is designed to lead integration of automated machinery into SHL IT and manufacturing operation systems to execute the development, implementation, and qualification of data handling systems for automated equipment. You will work closely with external vendors and SHL IT teams, ensuring seamless integration from development to qualification. This role also requires expertise in Data base, Networks, MES, ERP, Windows domain integration, and cybersecurity to support scalable and secure automation processes.

Main Responsibilities

• Data Handling System Development:

• Define user requirements for data handling systems for fully automated machines, covering production operational requirements (e.g., regular checks, HMI, user management, equipment modes, feeding/unloading systems), quality control (QC sampling, production reporting, OEE), and IT/OT system integration in compliance with GAMP 5.

• Collaborate with external vendors and internal IT teams to develop, test, integrate, and qualify systems.
• System Integration and Network Management
• Integrate equipment into the SHL network, ensuring seamless data exchange with MES, ERP, and Windows domain environments.
• Develop secure data exchange strategies using OPC UA for IT and OT system integration.
• Communicate and collaborate with vendors to align on network architectures, including Layer 2/Layer 3 designs, VLAN segmentation, and subnet planning, ensuring compatibility with SHL's IT infrastructure.
• Develop network infrastructure stategies for IT and OT systems, including switches, routers, firewalls, and industrial Ethernet devices such as PROFINET and EtherNet/IP.

• Troubleshoot network-related issues during machine development, qualification, and operational phases to minimize downtime and maintain system reliability.

• Regulatory and Compliance:

• Ensure compliance with 21 CFR Part 11, including electronic record management, audit trail, and user permissions.

• System Qualification:

• Lead the integration and qualification of new automated equipment with existing IT/OT systems, ensuring regulatory compliance and seamless operations.

• Develop and execute validation protocols aligned with 21 CFR Part 11.

• Assist in Documentation completion and review including and not limited (internal guide line and rules, URSs (User Requirement Specification), SDS (Software Design Specification), FAT, SAT)

• Cybersecurity and Compliance:

• Work closely with the IT team to implement cybersecurity measures, protecting both IT and OT data integrity.

• Maintain compliance with 21 CFR Part 11 and other relevant standards.
• Continuous Improvement
• Optimize data handling and system integration through data analysis, performance monitoring, and upgrades.
• Develop automation tools and algorithms for real-time data analysis and system optimization.
• Collaborate with cross-functional teams to improve both mechanical and control aspects of automated equipment.
• Documentation and Reporting
• Maintain detailed and accurate documentation for IT/OT integrations, cybersecurity measures, and compliance activities.
• Develop and update Guidelines, Work Instructions (WIs), and Standard Operating Procedures (SOPs) to standardize IT/OT processes and ensure consistent implementation.
• Facilitate regular reviews and updates of documentation to reflect changes in processes, technologies, and compliance standards.

Minimum Qualifications

• Bachelor's or master's degree in Automation, Mechanical Engineering, Computer Science, or a related field.
• At least 3+ years of experience in production related environment and/or in software related function
• Strong expertise in IT/OT systems, data handling, network communication, and system integration.
• In-depth understanding of mechanical and control systems for automated equipment.
• Familiarity with industry standards and regulatory compliance (21 CFR Part 11, GAMP 5) and cybersecurity in IT/OT environments
• Programming: Proficiency in Python, JavaScript, C#, or similar
• Industrial Automation: Beckhoff PLC (TwinCAT), and structured text, Knowledge and programming experience of PLC, IPC and/or SCADA (nice to have)
• Data Handling: Experience with databases, CSV file processing, and data visualization.
• Networking: CCNA, CCNP or other networking related certifications/experience
• Cybersecurity: Understanding of cybersecurity principles and best practices.
• Strong problem-solving and analytical abilities.
• Excellent communication and teamwork skills for collaboration across disciplines.
• Proactive, self-motivated, and eager to learn new tools and technologies.
• Strong intercultural and interdisciplinary communication skills in English (spoken/written).

Preferred Qualifications

• Programming: Software for data base (nice to have).
• Previous involvement in automation systems, process development, or industrial software development is a plus.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

For more information on SHL Medical, please visit: shl-

Please note: We do not accept applications from recruitment agencies for this position.