About Usten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.
Your missionWe are looking for a Senior Automation & OT Engineer to develop our automation strategy while ensuring the day-to-day reliability, compliance, and continuous improvement of the operational technology running our production equipment. Sitting at the intersection of automation engineering and IT operations, you will lead complex projects and act as the primary technical expert for the shop floor. You will balance hands-on troubleshooting of PLCs and servers with structured, GMP-compliant change management to support safe, efficient manufacturing.
Key Responsibilities
- Strategy & Leadership: Co - develop and support the site's overall automation strategy. Manage project pipelines, budgets, CAPEX/OPEX engineering tasks, and end-to-end hardware/software lifecycle planning.
- Systems Operations & IT: Execute daily maintenance and troubleshooting for automation hardware (HMIs, PLCs). Administer if applicable underlying IT infrastructure, including Windows Servers, OS patching, OT network segmentation, and cybersecurity hygiene.
- Process Equipment Expertise: Oversee automation systems for critical fill and finish operations, including filling lines, isolators, freeze dryers, autoclaves and building utilities.
- GMP & CSV Compliance: Ensure strict adherence to cGMP, Data Integrity, and CSV regulations. Draft and update technical documentation, execute rigorous change control, and support validation activities.
- Disaster Recovery: Maintain and regularly test backup/restore and disaster recovery procedures to ensure the uptime and validated state of all production equipment.
- Cross-Functional Collaboration: Partner with manufacturing, QA, and maintenance teams to optimize systems. Manage vendor SLAs, maintain spare parts inventory, and provide on-call support for critical system alarms.
Your profileWe are looking for a motivated and committed professional who is ready to actively grow with us, combining in-depth technical knowledge with a pronounced cooperative spirit.
The ideal candidate possesses:
- Degree in Computer Science, Information Technology, Automation, Engineering, or a related technical field.
- 5+ years of hands-on industrial automation or IT experience within a GMP Pharma environment, ideally with direct exposure to fill and finish operations.
- Strong technical proficiency in automation hardware (PLC & SCADA Systems), HMI/SCADA configuration, Windows Server administration, and OT cybersecurity fundamentals.
- Proven leadership experience with excellent communication skills, structured problem-solving under pressure, and a strong ownership mindset.
- Deep familiarity with GMP/CSV concepts (GAMP 5, EU GMP Annex 11, 21 CFR Part 11) and modern data integration architecture.
- Fluent in English (working language); German is a strong advantage for on-site shop floor communication.
Why us?We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.
Here's what sets ten23 apart:
- A valuable and impactful career development opportunity in an inspiring environment
- Flexible working arrangements and environment with an open culture and diverse workforce
- The opportunity to work with and learn from highly qualified and experienced employees
- Our learning and self-developing culture offers a wide range of training options
- Competitive pension fund plan, annual bonus, and other financial and non-financial benefit
At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.ContactFor more information and clarification, please connect Amrith ----- from our Talent team!
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