QA Specialist – CSV & QV

In Bern, we’re not just expanding—we’re reaching a major milestone by launching a new production site and introducing innovative ways of working. This is what being a Persistent Pioneer in our BN DNA is all about—bringing a pioneering spirit to everything we do. Whether you’re an experienced professional, transitioning from academia, or coming from a related industry, you’ll have the unique opportunity to influence how we work and grow. 

Boost our team 

In this key role, you will help ensure high quality standards and contribute to the delivery of safe and effective pharmaceutical products. 

In this role you will oversee and provide leadership for all Computer System Validation (CSV) activities, as well as Qualification, and Validation (QV) processes at the site. You will ensure compliance with regulatory requirements, internal quality policies and industry best practices, supporting the development and manufacture of safe, effective and compliant products. 

Your tasks 

• Develop, review and approve CSV and QV strategies, plans, protocols and reports for new and existing facilities, utilities, equipment and computerized systems 

• Partner with cross-functional teams such as Engineering, Manufacturing, IT and other Quality services to ensure compliance and timely project execution 

• Participate in audits and inspections in relation to CSV and QV, ensuring readiness and robust documentation 

• Drive a culture of quality, compliance and continuous improvement within CSV and QV activities, mentoring team members and stakeholders as needed 

• Support changes and corrections in relation with CSV and QV

• Act as subject matter expert (SME) for relevant regulations and guidelines, including EU GMP (EudraLex Volume 4, Annex 11 and 15) and FDA 21 CFR Part 11 

About you 

• University degree in engineering, life sciences, computer science or a related field 

• Minimum 5 years of experience in CSV and ideally QV within the pharmaceutical, biotechnology or related regulated industry; Experience in QA would be a plus 

• Demonstrated capability to drive and coordinate complex validation projects in a cross-functional environment with multiple stakeholders 

• In-depth knowledge of cGMP, GAMP, FDA, EMA and other relevant regulations and guidelines 

• Strong technical writing, problem-solving, and project management skills 

• Excellent written and spoken English skills; German is an advantage, combined with strong interpersonal and communication abilities  

We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and professional skills.