Global Development Engineering and Automation Specialist

vor 1 Woche


Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit
Join Our Team as a Global Development Engineering and Automation Specialist

We are seeking a highly skilled and experienced Global Development Engineering and Automation Specialist to join our team at AbbVie. As a key member of our Combination Products Development (CPD) team, you will play a critical role in driving quality improvement and ensuring compliance with regulatory requirements.

Key Responsibilities:
  • Align strategy with all CPD sites and stakeholders of interface departments to ensure seamless collaboration and effective quality improvement.
  • Lead and guide quality improvement initiatives across all sites with matrix responsibilities, developing a quality data integrity concept to drive excellence.
  • Supervise the design and development of equipment and combination products to ensure compliance with relevant regulatory requirements and guidelines, including FDA, EMA, and ISO standards.
Requirements:
  • BS or equivalent education and extensive experience (14+ years) in a relevant field, or MS or equivalent education with 12+ years of experience, or PhD with 6+ years of experience.
  • Significant experience with quality strategies, including qualification, validation, and 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, is preferred.
What We Offer:
  • A dynamic and challenging work environment with opportunities for professional growth and development.
  • A diverse and inclusive work environment where you can have a real impact.
  • An attractive salary and comprehensive benefits package.
  • Flexible work models for a healthy work-life balance.
  • Access to top-tier development opportunities and a strong international network.

We are committed to equality, equity, diversity, and inclusion (EED&I) and strive to create an inclusive culture where all employees feel valued and respected. If you are passionate about improving global healthcare and want to contribute to making a difference in patients' lives, we encourage you to apply. Please submit your complete CV, and we will discuss the details with you in person.



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