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Development & Automation Engineer (all genders) Combination Products (permanent / full-time)

AbbVieLudwigshafen, Rhineland-Palatinate, Germany

Vor 30+ Tagen

Stellenbeschreibung

Job Description

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

Qualifications

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

Additional Information

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!

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more :

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