Senior Software Validation Engineer - Quality Assurance (all genders) - Allergan : Job Details

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 TikTok.

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 to address some of tomorrow's 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 to develop and increase your skills? You've 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 the 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.

This is how you make a difference:

• Graduated Engineer (FH) in Biotechnology, other engineering disciplines, 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 fields such as regulated GxP environment in software qualification/validation, documentation, or compliance.
• Sound knowledge of 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 change initiatives.
• Excellent communication skills and teamwork capacities, on a local and global level.
• Excellent knowledge of English and German (spoken and written).

What we offer you:

• A diverse work environment where you can have a real impact
• An open corporate culture
• An attractive salary
• An intensive onboarding process with a mentor
• Flexible work models for a healthy work-life balance
• Corporate health management with comprehensive health and exercise programs
• Company social benefits
• Wide range of career opportunities in an international organization
• Top-tier, attractive development opportunities
• A strong international network

We have been recognized multiple times as a Great Place to Work and are committed to equality, diversity, and inclusion (EED&I). We focus on giving back to our communities and are dedicated to creating an inclusive culture where all employees are treated with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be part of our success, grow with us, and accomplish more than you imagined. Interested? We look forward to your complete CV and discussing everything else in person.

Questions? Email us at [email protected]. We look forward to hearing from you!

AbbVie commits to equal opportunities and working with integrity, driving innovation, changing lives, and serving our community. Equal opportunity employer for veterans and persons with disabilities.