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Senior Quality Engineer for Combination Products

vor 1 Monat


Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit

Transforming Possibilities into Reality

The role of a Development & Automation Engineer at AbbVie is a unique opportunity to make a meaningful impact on patients' lives. As part of our international team, you will collaborate with colleagues worldwide to address unmet medical needs and improve global healthcare.

Key Responsibilities

  • Strategic Alignment
    • Lead quality improvement initiatives across all CPD sites and interface departments, ensuring compliance with regulatory requirements and guidelines.
    • Develop and implement quality data integrity concepts, driving matrix responsibilities and global quality excellence.
  • Subject Matter Expertise
    • Provide technical expertise for tech transfer activities, method development, and process validation for drug delivery devices.
    • Supervise the design and development of combination products, ensuring compliance with FDA, EMA, and ISO standards.
  • Lab Support and Design Verification
    • Create and review test protocols and reports, supervising the execution of exploratory and verification testing.
    • Analyze data, document results in lab notebooks, and present findings to cross-functional teams.
  • Software Tools and Compliance
    • Represent the company in software evaluation and data integrity, ensuring compliance with applicable policies and procedures.
    • Comply with regulatory and safety requirements, including ICH and ISO guidelines, Good Manufacturing Practices, and Design Controls.

Requirements

  • BS or equivalent education, with 14+ years of experience, or MS with 12+ years of experience, or PhD with 6+ years of experience in a relevant scientific area.
  • Significant experience with quality strategies, including qualification, validation, and transfer.
  • Knowledge of ICH and ISO guidelines, Good Manufacturing Practices, Design Controls, and FDA regulations.
  • Experience with Electronic Lab Notebook software and electronic DHF tools, such as Polarian.
  • Strong communication skills, including written and verbal, with the ability to influence without direct authority.
  • Flexibility and adaptability to work in a dynamic environment, with a keen eye for identifying project risks and developing mitigation plans.
  • Experience with equipment, including computer numerical control and automated features, is a plus.
  • Strong problem-solving and analytical skills, with a strong understanding of engineering fundamentals and basic statistics.

About AbbVie

At AbbVie, we value diversity, equity, and inclusion, and we strive to create an inclusive culture where all employees can thrive. We are committed to equality and respect for all individuals, regardless of their background, gender, origin, religion, or other dimensions of diversity.

We offer a dynamic work environment, an attractive salary, and a range of benefits, including flexible work models, comprehensive health and exercise programs, and a strong international network. Join us in our mission to make a meaningful impact on patients' lives and contribute to the development of innovative solutions for unmet medical needs.