Associate II, Integrated Downstream Quality Operations
Associate II, Integrated Downstream Quality Operations
- Full-time
- Region: EU+/Canada
Job Description
About This Role
The Associate II within the Integrated Downstream Quality Operations team is part of the Quality Department at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/She focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment. The Solothurn site is intended to operate with a fully integrated electronic batch record for all commercial, clinical and PPQ campaigns.
What You'll Do
- Executes QA activities related to downstream operations, GMP manufacturing, and downstream equipment to ensure the safety, efficacy and purity of the products manufactured by Biogen
- Reviews and approves GMP Engineering and Manufacturing documents during both project and operational phases of the site, specifically related to procedures, work instructions, CAPAs, deviations, change control, equipment (work orders, P&IDs, qualification protocols, calibration deviations..,) etc.
- Partners with Manufacturing, Manufacturing Sciences, Process Engineering, Automation SMEs during deviation management and investigations.
- Ensures adherence to internal procedures during downstream manufacturing operations or for equipment controls and release before and during GMP CAPEX and OPEX project (i.e., shutdowns, construction projects) or New Product Introduction
- Participates in batch record review and close out in the view of batch release.
Who You Are
You have a background in chemical engineering, bioengineering, or related fields, with experience in pharmaceutical or biotech manufacturing. As a person you are inclusive, and act with integrity. You have strong problem-solving, organizational, and communication skills, and the ability to work autonomously and collaboratively in a cross-functional environment.
Qualifications
- Bachelor’s degree in relevant field such as Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations and at least 4 years of experience in pharmaceutical or biotech manufacturing environment.
or
- Master’s degree in relevant field such as Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations and at least 2 years of experience in pharmaceutical or biotech manufacturing environment.
- Experience with Quality Assurance, Equipment Qualification, Downstream Process is preferred.
- Demonstrated ability to work autonomously with cross-functional team members.
- Strong presentation and organizational skills
- Demonstrated writing skills
- Demonstrated problem solving skills
- English B1 as a minimum.
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. Read on to learn more about our DE&I efforts.
