(Senior) Software Validation Engineer - Quality Assurance (all genders) (fulltime, regular)

• 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.
• Advise project teams, Business System Owners, and Business SMEs on risk-based CSV / CSA strategy, validation planning, testing approach, traceability, and documentation expectations for new systems and system changes.
• Review / approve various software qualification / validation documentation, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.
• Provide technical guidance, coaching, and training to RDQA colleagues and business partners on CSV / CSA, data integrity, validation, and quality system expectations.
• 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.
• Participate in process improvement projects and assist with the development of compliance plans and strategies.

Qualifications

• Graduated Engineer (FH) or bachelor's degree in natural sciences, 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 qualification / validation, documentation, or compliance.
• Key leadership competencies to include relationship-building, ability to influence, knowledge of the business, sound judgment, conflict resolution, excellent interpersonal skills.
• Ability to provide innovative ideas to improve quality and compliance that create value, always seeking new information and insights (internal and external).
• Excellent communication capabilities and teamwork capacities, on a local and global level.
• Excellent knowledge of the English and the German language (spoken and written).

• Experience with development, oversight, validation, or governance of AI/ML-enabled technologies, advanced analytics platforms, automation solutions, or digital quality systems, including application of risk-based assurance and data integrity principles.
• Knowledge of emerging industry guidance related to AI/ML, computerized systems quality, and digital health technologies.

• 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 TalentAcquisition.de@abbvie.com - We are looking 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