Senior Associate II, QA Downstream

Senior Associate II, QA Downstream

• Full-time
• Region: EU+/Canada
• Department: Quality

Job Description

About This Role

The Senior Associate II, QA Downstream will support the ongoing production and maintanance of the new Large Scale Manufacturing facility located in Luterbach, Switzerland.

It is a technically orientated role requireing experience of the validation of production equipment and knowledge of production methodology involved in biopharmaceutical drug substance production.

This role is responsible for Quality oversight on manufacturing process which includes but not limited to Deviation management, Change control, CAPA, deviations, Work order, batch review, protocols and documentation review in the scope of Facilities, utilities, equipment and Biogen Execution System (global and local computerized systems).

The QA will work with systems that control key functional, tactical and operational aspects within the Quality Assurance organization at the Biogen Solothurn Facility and will support QMS with authoring, review and approving.

This position requires cooperation with people at every level of the organization and from multiple functions, including engineering, automation, validation, Manufacturing personnel, SME’s on equipment and knowledge of biotechnology API production.

What You'll Do

• Provide support to manufacturing areas within the facility for deviations, root cause analysis and CAPAs related to equipment and automation of the production process and applying regulatory and compliance knowledge from multiple markets/agencies.
• Review and approve complex GMP documentation (Changes, plans, protocols, technical documentation, etc.) related to modifications of existing equipment and automation and may participate on projects requiring a high knowledge level of regulatory and Biogen Quality and Process systems.
• Act on internal and external audit as SME and response to potential observations.
• Ensure continuous improvement in perspective of making processes and systems more robust and compliant.
• Support on deliverable related to batch operations (WO review, batch review, KPIs definition and monitoring).

Qualifications

• 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.

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.