Process Engineering Lead, Drug Product External

vor 3 Monaten

Bern, Schweiz CSL Behring Vollzeit

This role requires significant international travel.

**Responsibilities**:

- Lead transition of technical oversight from project (tech transfer) to operations phases for DP external manufacturing
- Ensure that key parameters for process monitoring are identified and charts (e.g. time series, control charts) are set up and maintained
- Ensure key process and asset attributes relevant to reducing variability are tracked, increasing performance of the process and visualizing in reporting
- Evaluate long-term trends, maintain log of loss drivers (e.g. performance, availability and quality losses), identify improvement levers, and plan robustness and continuous improvement initiatives
- Support deviations linked to process robustness, train and coach others on how to interpret robustness trends, actively liaise with other functions to identify loss drivers, including aseptic process/technology owner, QA specialist and broader Global Engineering
- Participate in cross-functional, external plant operations teams, act as single point of contact (SPOC) for Engineering in such teams, engage broader organization to drive problem solving capability and lead investigations through the use of problem-solving tools
- Provide technical person in plant (PIP) support for routine CMO operations as required and in conjunction with Quality PIP. Represent CSL Behring at technical interface with CMO partners
- The position doesn't include direct reports

**Qualifications & Experience**:

- University degree in engineering or science; higher degree preferred
- Aseptic/sterile processing and visual inspection of bio pharmaceuticals in one or more of Operations, Process Engineering or Quality Assurance (5+ years post graduate experience)
- Fluency in German and English
- Experience in GMP, problem solving, continuous improvement, vendor relationships, data analysis & interpretation

**Additional Comments**:
This is a matrix leadership role working with internal and external partners to deliver reliable, efficient, on-time performance from the CMO network for DP manufacture. As such, the ability to work across national and cultural boundaries, honed analytical skills, detailed planning, and interpersonal savvy to achieve partner buy-in for strategies and plans will be essential for success. An ability to resolve routine issues at point whilst maintaining an acumen for stakeholder management and escalation of topics impacting product supply, multimillion dollar provisions or patient safety will also be required.

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

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