Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

People. Passion. Possibilities. Three words that make a world of difference.

More than a job. It's a chance to make a real difference.

Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

Together, we break through – as Senior Software Validation Engineer - Quality Assurance (all genders)

The Senior Software Validation Engineer - Quality Assurance (QA) will be primarily responsible for providing interpretation, guidance, training and support regarding software qualification / validation activities and data integrity.

Make your mark:

• Provide interpretation, guidance, and training for business partners regarding software qualifications / validation and related regulatory regulations / guidelines, including data integrity and AbbVie policies / procedures.
• Support Business System Owner and Business SME with their IT software projects and goals.
• Review / approve various software qualification / validation documentation, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.
• Defend software qualification / validation during regulatory authority inspections and third-party audits.
• Support business in understanding the process of inspection/ audit responses.
• Recommend a plan of action for satisfactory resolution of quality and regulatory compliance issues.
• Participate in CAPA activities, provide support to event owners and Business System Owners, review and approve related records.
• Provide guidance, direction, and support to R&D QA staff.
• Lead or participate in process improvement projects and assist with the development of compliance plans and strategies.

Qualifications

This is how you make a difference:

• Graduated Engineer (FH) in Biotechnology, other engineering discipline, natural sciences, pharmacy; or natural scientific apprenticeship, or other equivalent professions, all with several years of experience in drug product development or production or validation / qualification in the pharmaceutical field.
• Minimum of 5 years of experience in Quality Assurance or related field such as regulated GxP environment in software qualification / validation, documentation, or compliance.
• Sound knowledge of the current regulatory requirements (EU GMP Annex 11 / 15, ICH, PIC/S¸ FDA 21 CFR Part 11), Engineering Standards and Best Practices.
• Proven ability to work in a global environment and on virtual teams.
• Experience leading cross-functional teams or changing initiatives.
• Excellent communication capabilities and teamwork capacities, on a local and global level.
• Excellent knowledge of the English and the German language (spoken and written).

What we offer you:

• with a diverse work environment where you can have a real impact

• with an open corporate culture
• with an attractive salary
• with an intensive onboarding process with a mentor at your side
• with flexible work models for a healthy work-life balance
• with a corporate health management that offers comprehensive health and exercise programs
• with company social benefits
• with a wide range of career opportunities in an international organization
• with top-tier, attractive development opportunities
• with a strong international network

At multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.

Any questions? Feel free to email us at [email protected] – We look forward to hearing from you!

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html