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 Twitter, Facebook, Instagram, YouTube and LinkedIn. 

The job that makes possibilities real in patients' lives. And yours.

The job that helps you get ahead in life. Moving mountains together.

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? You’ve come to the right place!

Moving mountains together – as Development & Automation Engineer (all genders) Combination Products (permanent / full-time)

Responsibilities

• Align strategy with all CPD sites and stakeholders of interface departments
  • Global role: lead and guide quality improvement through all sites with matrix responsibilities and developing a quality data integrity concept
  • Supervise: Ensure that equipment and combination products are designed in compliance with relevant regulatory requirements and guidelines, including FDA, EMA, and ISO standards
• Subject matter expert (SME): for tech transfer activities and method development for drug delivery devices, including experience developing and implementing process validation and control strategies.  SME for local/global GMP and non-GMP test equipment including automated equipment selection used for combination product development and Design Verification testing
• Lab Support: Create and/or review test protocols and reports and supervise execution of exploratory and verification testing, analyze data, document in lab notebooks, and present results to cross-functional teams
• Design Verification: Author verification protocols and reports. Support investigations and issue resolutions
• Software Tools: Representative for Software evaluation and data integrity
• Complies with applicable policies and procedures, regulatory and safety requirements

• BS or equivalent education and extensive, Typically, 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline
• Significant experience with quality strategies including qualification, validation, transfer
• Knowledge of ICH and ISO Guidelines, Good Manufacturing Practices (GMP), Design Controls, Good Documentation Practices (GDP), and FDA regulations
• Experience with Electronic Lab Notebook (ELN) software and electronic DHF tools such as Polarian are preferred
• Documentation experience including technical reports, design verification plans, protocols, etc.
• Detailed understanding of principles and practice of Design Controls (CFR 820.30 / ISO 13485) and Risk Management (ISO 14971), ISO 13485, 21 CFR Part 820, and ICH Q10
• Strong communication skills (both written and verbal) including the ability to influence without direct authority
• Knowledge of relevant regulatory requirements and guidelines, including FDA, EMA, and ISO standards
• Flexibility and adaptability to work in a dynamic and rapidly changing environment
• A keen eye for identifying project risks and proactively developing mitigation plans
• Experience with equipment including computer numerical control (CNC) and automated features is a plus
• Strong problem solving and analytical skills
• Strong understanding of engineering fundamentals
• Knowledge in basic statistics and Six Sigma statistical techniques is a plus
• Self-driver with proven track record of actively engaging and working in a matrixed environment with cross-functional teams and getting things done
• Other attributes include strong decision making, communication (spoken and written) skills, attention to details, and commitment to accuracyacos

Here's how we can move mountains together

• 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

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 as at [email protected] – we look forward to hearing from you!

Nur gemeinsam können wir das Beste für Patienten erreichen. Daher setzen wir bei AbbVie auf Chancengleichheit, Vielfalt & Inklusion. Wir gestalten ein Arbeitsumfeld, in dem alle Mitarbeiter ihr Potenzial entfalten können – unabhängig von Geschlecht, Herkunft, Religion, sexueller Orientierung oder anderen Vielfaltsdimensionen. Doch für uns bedeutet Vielfalt mehr als nur offensichtliche Unterschiede zu berücksichtigen: Sie bezieht sich auch auf unterschiedliche Ausbildungshintergründe, Fachkenntnisse, Persönlichkeitstypen, Denkweisen und Lebenserfahrungen.