Validation Subject Matter Expert (m/f/d)
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat people with life-threatening medical conditions and to help them live full lives. The parent company, CSL Limited, is headquartered in Melbourne, Australia.
In May 2014, CSL selected Lengnau in the Canton of Bern in Switzerland as the location of a new manufacturing facility to support the commercial production of our promising novel therapies. In May 2020, CSL announced the strategic partnership with Thermo Fisher Scientific, the world leader in serving science. Thermo Fisher will lease and operate the Lengnau state-of-the-art biotech manufacturing facility once construction is completed in 2021. It is anticipated that employees at the site who are engaged for the operation of the site and the commercial production of our therapies in Lengnau will automatically transfer to Thermo Fisher Scientific once construction is complete. Today, more than 200 employees work in Lengnau.
You can find more information on the strategic partnership with Thermo Fisher here (https://www.cslbehring.com/newsroom/2020/thermo-fisher-and-csl) and some more information about the prospects of a future career with Thermo Fisher here (https://corporate.thermofisher.com/en/about-us.html).
We are looking for talented and dedicated personalities that share our passion to develop and deliver innovative therapies. With your commitment, reliability and high-quality standards you help us to improve the quality of life for those in need.
We are currently recruiting for a
Validation, Subject Matter Expert (m/f/d) - R-130380
- Defines, in collaboration with other stakeholders (Quality Assurance, System Owner…) the requalification strategy of GMP systems.
- Implements the requalification strategy in the relevant quality systems. (e.g. Periodic Review, periodic requalification work orders)
- Responsible for drafting, updating, training of Standard Operating Procedures and Work Instructions related to requalification and revalidation
- Oversees execution of activities by external contractors.
- May perform requalification and revalidation Work Orders, including routine and non-routine operations, and documents in forms and SAP-PM following Good Documentation Practices
- Investigates non conformities, especially root cause analysis and appropriate Corrective And Preventive Actions, and assists with the redaction of the findings
- Promotes Metrology services within the plant by offering support to other departments
- Participates in the culture of continuous improvement and development of technologies within Metrology functions
- Participates in calibration activities
- Act as the deputy for the Head of Metrology in their absence
We welcome early career profiles after graduation (Bachelors, Masters or PhD) and offer the opportunity for on-the-job development
- Holds a Master's degree, e.g. as Electrical, Mechanical Process, Automation, or Chemical Engineer, from a technical university, ETH or a Technical College
- 5 years of experience within the pharmaceutical industry ( 3 years of experience in a similar function related to Validation are desirable but we also welcome early career profiles after graduation (Bachelors, Masters or PhD) and offer the opportunity for on-the-job development
- Recognized further training(s) in the area of Validation preferred
- Experience in following Good Documentation Practices is preferred
- A conversational level in English and German languages is required
|Posted on:||26 Apr 2021|
|Job starts:||As soon as possible|
|Study areas:||Engineering, Engineering - Chemical, Engineering - Electrical, Engineering - Electronic, Engineering - Mechanical, Engineering - Technology, Manufacturing Sciences (including CAD - CAM - CAE)|