- Ensure Facility, Utilities, Equipment or computerized systems Qualification and Cleaning/Sterilization Validation are successfully executed according to current GMP and regulatory policies.
- Review and approval of Validation, Engineering and Manufacturing documents during both project and operational phases of the site.
- Review and approval of GMP documentation and data for compliance to applicable procedures, regulatory and/or corporate guidance documents.
- Responsible for QE activities (protocols, deviations, change control and CAPAs) associated to facility, utilities, equipment qualification and Cleaning Validation, or computerized system
- Support on Quality system activities ( KPIs, metrics, local SME)
- Bachelor's degree in relevant field such as Chemical Engineering, Mechanical Engineering, Bioengineering, Automation Systems.
- 8 years of experience in pharmaceutical or biotech manufacturing environment. Experience with Quality Assurance, Equipment Qualification, Equipment Cleaning Validation, Automation/MES or related function is preferred.
- Must have proficiencies with the Quality systems and, preferably, with business processes associated with automation and integration of testing and production systems.
- Demonstrated ability to work autonomously with cross-functional team members.
- Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors, and external partners effectively.
- Strong presentation and organizational skills
- Demonstrated problem solving skills
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, PowerPoint, Visio, etc.)
- Candidates with experience in drug substance (or API) and drug product are preferred.
- English B1 as a minimum.
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Senior Associate II, QA Downstream - Luterbach, Schweiz - Biogen
Beschreibung
About This Role
The Senior Associate II QA is being part of the Quality Compliance and Technical services team. This role is mainly responsible on Facility, Utilities and Equipment (FUE) Qualification and Validation at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/she is also responsible for the Quality oversight of the manufacturing facilities, engineering and utilities activities and local Biogen Execution Systems (BES) e.g., Delta V, Syncade and PLC driven equipment. The Solothurn site is intended to operate with a fully integrated electronic batch record.
What You'll Do
Qualifications
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about our DE&I efforts.
