Senior Automation Engineer PCS/MES

In the area of Automation Engineering at the Bern location, we are currently looking for the Value Stream Filling for a

Senior Automation Engineer PCS/MES-Filling (m/f/d)

As a successful Senior Automation Engineer, you will ensure reliable production in our aseptic and GMP-regulated filling plants. Together with your team colleagues, you are responsible for the operation, further development, and lifecycle support of the automation and Manufacturing Execution Systems (MES) in the area of Filling.

In addition to the realization of investment projects, you coordinate and implement changes for process optimization, compliance assurance, and troubleshooting on complex production systems. In doing so, you work closely with Production, Manufacturing, Quality, CSV, Engineering, IT, as well as external partners.

Your tasks include:

• Leading role in automation and MES projects as a sub-project manager Automation/MES
• Specification, implementation, commissioning, qualification, and lifecycle support of PCS 7, SIMATIC Batch, and Opcenter systems
• Creation, maintenance, and optimization of electronic manufacturing recipes (MBRs) and batch processes according to ISA-S88 and ISA-S95
• Configuration and further development of Siemens Opcenter Execution Pharma (MES) including interfaces to SAP, LIMS, Data Historian, and Package Unit systems
• Analysis and resolution of complex production disturbances as well as conducting root cause analyses
• Support of GMP-relevant activities such as CAPAs, Deviations, Change Controls, and inspections
• Creation and review of GMP documentation, specifications, risk analyses, test, and qualification documents
• Support of FAT, SAT, Commissioning, IQ/OQ/PQ, and CSV activities
• Ensuring reliable operation of the production and automation systems
• Implementation of process improvements and digitalization initiatives to increase efficiency, quality, and plant availability
• Supervision and control of external integrators and suppliers.

What you bring with you:

• Bachelor's or Master's degree in Automation, Electrical Engineering, Computer Science, Process Engineering, or a comparable qualification
• At least 5 years of professional experience in the field of automation and MES in a GMP-regulated environment, preferably in the pharmaceutical industry
• Sound knowledge of Siemens PCS 7 and Batch
• Sound knowledge of Siemens Opcenter Execution Pharma
• Experience with pharmaceutical manufacturing processes, ideally in the area of aseptic filling
• Very good knowledge of GMP requirements as well as experience with CSV, Data Integrity, Annex 11, and GAMP 5
• Knowledge of the standards ISA-S88 and ISA-S95
• Experience in the technical leadership of projects as well as in collaboration with interdisciplinary teams
• Strong analytical skills as well as a structured and independent way of working
• Very good German and English skills in speaking and writing round out your profile

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.