CSL Behring Head of QC Excellence Instrumentation (m/f/d) in Bern, Switzerland
With operations in 35+ nations and 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring (http://www.cslbehring.com) is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma (http://www.cslplasma.com/careers) , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
CSL Behring is a global biotherapeutics leader driven by its promise to save lives.
We are currently looking for a
Head of QC Excellence Instrumentation (m/f/d)
In the role as Head of QC Excellence Instrumentation (m/f/d) you will lead a team of instrumentation specialist to support laboratory instrumentation and automation infrastructure in an operational testing environment. With your team you make sure equipment operates in an environment according to company policies and procedures and in compliance with GxP requirements.
In detail, your responsibilities include:
Oversee and lead a team of instrumentation specialist, support laboratory instrumentation and automation infrastructure in an operational testing environment
Ensure laboratory instrumentation and equipment are qualified, calibrated and maintained according to company policies and procedures and in compliance with GxP requirements
Support the qualification, validation and lifecycle management of existing and newly implemented laboratory automation systems and software applications in collaboration with Laboratory Execution Systems
Maintain working knowledge of regulations and guidelines as related to laboratory instrumentation and computerized systems (i.e. USP, 21CFR Part 11, Annex 11 regulations) to ensure compliance with guidelines and industry best practice
Establish and maintain user support for operational QC labs on instrumentation and equipment by establishing instrument operation and maintenance procedures, providing technical support and coordinating repairs and support through QC external providers (i.e. Laboratory Execution Systems, I&T, external service providers)
Participation and representation of QC in regulatory inspections as related to instrumentation, automation and equipment qualification and lifecycle activities
Develop, establish and improve lean processes in regards to instrumentation lifecycle activities, collaborating with a team across all manufacturing sites within the CSL Behring network
Who you are:
In this role you will collaborate with relevant stakeholders to ensure laboratory equipment and automation systems are operating in a qualified environment. With your proactive and self-responsible approach you take decisions and drive progress forward.
The below competencies furthermore contribute to your success:
University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, etc.)
5+ years' experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation, including experience in equipment qualification and maintenance activities
First management and leadership experience in an operational environment
Knowledge of regulations on computerized systems and laboratory automation, technical writing skills
Strong written & verbal communication. Effective collaboration with peers, cross-functional teams and users across the organization and across all CSL Behring sites globally
Strong analytical/problem solving and organizational skills
Able to work independently and as a team member in a high performance environment
Worker Sub Type:
CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement
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