Manger Engineering, Solution Supply

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Our Schachen serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees feel not only that they belong at Schachen, but that the site belongs to and is shaped by them.

The Biotech facility, at our Schachen, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. our Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline.

The **Manager Engineering, Solution Supply (M/F/d)** has a variety of key responsibilities.

**Main Responsibilities**:
- Leading the Solution Supply team engaged in daily operations: weighing and dispensing of raw material, preparation and dispensing of cell culture media and buffer used in the fed-batch and continuous manufacturing of mAb.
- Plan day to day shop floor operations, in alignment with facility schedule.
- Act as first level support in the event of problems on the shop floor.
- Maintaining area in GMP Compliance.
- Ensure full support to Good Manufacturing Practice (GMP) Drug Substance Manufacturing to seamless share resources to allow business continuity.
- Perform investigations, root cause analysis and risk assessment to support deviations and change controls.
- Overseeing and maintaining departmental procedures and practices to ensure efficient operation and continuous improvement, GMP documentation such as Standard Operating Procedure (SOPs), Batch Records, Buffer Memo, Qualification and Validation Protocols.
- Implement new technologies with software and instruments that can simplify and reduce effort around manufacturing and administrative processes.
- Ensure the highest Quality, Compliance and Safety standards.
- Inspire Diversity and Inclusion - building working effective working relationship within a cross-functional team across different cultures and backgrounds.
- Embody Safe by Choice and know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals.
- Collaborating across the network on sharing best practices and lessons learned, embodying an enterprise mindset in looking at what can be leveraged across the network to reduce work that needs to be done locally.

**Required Education, Experience and Skills**:

- Degree level qualification in science or engineering, with People Manager Experience.
- Demonstrated experience (5 years minimum) in a GMP-regulated drug substance manufacturing environment, ideally with experience of single-use systems.
- Competent in analyzing complex situations and showing practical problem-solving capabilities.
- Experience with quality management and compliance systems and Strong technical writing abilities.
- Oral and written communication skills in German and English.

**Preferred experience and Skills**:

- Process understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing being a significant advantage.
- Delta V and MES (Manufacturing Execution System) knowledge and experience is an advantage.
- Problem, Deviation, and Change Management experience.
- Experience as a Project Manager with cross-functional team members or Managing Staff.

**THE COMPANY**

Our Company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.

Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.

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