About this role
About the Role Join our production site in Pfaffenhofen/Ilm as Operations Engineer for antibody manufacturing and bioconjugation (m/w/d). In the project phase you will collaborate closely with the antibody manufacturing and bioconjugation project leaders, the project team, external service providers, and the overall project manager to implement automation and MES interfaces while ensuring GMP and EHS compliance. What You'll Do
- During the project phase, collaborate with the project leaders of antibody manufacturing and bioconjugation, the project team, external service providers and the overall project lead.
- Contribute to the setup of the PLC system (e.g., Siemens PCS 7) for various production facilities, considering manufacturing process requirements.
- Perform tests to verify functional blocks in the computer system and recipe the production processes.
- Participate in FATs and SATs with a focus on automation.
- Consider interfaces between PLC and MES systems.
- Create spare parts lists for the production facilities.
- Conduct trainings.
- After commissioning: provide technical support for process plants with a focus on automation and plan upgrades/optimizations.
- Ensure GMP- and EHS-compliance of the technical equipment and its readiness.
- Troubleshooting, root-cause analyses and support the operations department in GMP-compliant deviation handling and the implementation of CAPA measures and Change Control procedures.
- Create SOPs, risk assessments and hazard analyses and conduct employee trainings.
- Analyze production- and plant-relevant data.
- Contribute to FATs, SATs together with Engineering.
- Work closely with Engineering, EHS, IT, the central automation group and suppliers.
- Contribute to the preparation and execution of audits and inspections. What We're Looking For
- Completed degree in pharmaceutical technology or engineering/process engineering or equivalent qualification.
- Several years of experience operating pharmaceutical/biotechnological plants, and in particular PLC systems (e.g., Siemens PCS 7) in the pharma environment.
- Good knowledge of pharmaceutical/biotechnological manufacturing processes, equipment qualification and EHS requirements.
- Sound knowledge of regulatory requirements (national and international).
- Affinity for digital and innovative technologies.
- Proficient MS Office and SharePoint skills.
- Good teamwork and communication skills, precise working style and flexibility.
- Assertiveness, independent working style, commitment and resilience, hands-on mentality.
- Very good German and English skills, both written and spoken. Nice to Have
- Experience with digital technologies and automation projects. Compensation & Benefits
- Salary and benefits not specified in the posting.