Scientist II Senior Scientist I in Engineering – Method Development (all genders) (full-time, p[...]

Allergan; Ludwigshafen am Rhein; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A global pharmaceutical company in Ludwigshafen am Rhein is looking for a Scientist II / Senior Scientist I. This role involves developing innovative drug/device combination products and ensuring compliance with regulatory standards. The ideal candidate has extensive experience in test method development and design verification. Strong communication and problem-solving skills are essential. The company offers competitive salary and a diverse work environment with flexible work models.

Leistungen

Attractive salary

Flexible work models

Comprehensive health programs

Qualifikationen

• 5+ years of experience in medical devices or combination products.
• Comprehensive background in operating and maintaining material testing equipment.
• Strong understanding of engineering fundamentals with strong problem solving and analytical skills.

Aufgaben

• Subject Matter Expert for Test Method Development of delivery devices.
• Execute test protocols supporting exploratory and verification testing.
• Implementing process automation and digitalization initiatives.

Kenntnisse

Test Method Development

Design Verification

Analytical Modelling

Strong Communication Skills

Problem Solving Skills

Ausbildung

Bachelor's Degree

Master's Degree

PhD

Tools

Zwick Universal Test Machine

Electronic Lab Notebook (ELN)

DHF tools such as Polarian

Jobbeschreibung

Company Description

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.

Job Overview

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 tomorrow's 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 for developing and increasing your own skills? You've come to the right place!

Moving mountains together – as Scientist II / Senior Scientist I in Engineering – Method Development (all genders) (full-time, permanent)

We are looking for an experienced Senior Scientist I, Engineering – Method Development (all genders) to join our Device and Combination Product Development to contribute to the development of exciting new drug/device combination products.

Responsibilities

• Subject Matter Expert (SME) for Test Method Development of delivery devices and combination products: Test Method development, including best practices for universal implementation, Test Method Validation/Transfer.
• Design Verification: Author verification protocols and reports. Support investigations and issue resolutions.
• Execute test protocols supporting exploratory and verification testing, analyze data, document in lab notebooks, and present results to cross-functional teams. Utilize Zwick Universal Test Machine (UTM) and other GMP and non-GMP test equipment used for combination product development and Design Verification.
• Software Tools: Utilize Electronic Lab Notebook (ELN) software and electronic DHF tools such as Polarian.
• Implementing process automation and digitalization initiatives to enhance efficiency and reliability in device development and manufacturing processes.
• Utilizing analytical modelling for key performance attributes and ensuring compliance with regulatory requirements, including FDA, EMA, and ISO standards.

Qualifications

• Scientist II: Bachelor Degree or equivalent education with typically 7 or more years of experience or Master Degree or equivalent education with typically 5 or more years of experience. 5+ years of experience in medical devices or combination products.
• Senior Scientist I: Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD and no (some) experience necessary.
• Proficiency and knowledge in the design and testing of injection devices and combination products.
• Comprehensive background in operating and maintaining material testing equipment.
• Strong communication skills (both written and verbal) including the ability to influence without direct authority.
• Knowledge of ICH and ISO Guidelines, GMP, Design Controls, GDP, and FDA regulations.
• Documentation experience including technical reports, design verification plans, protocols, etc.
• Strong understanding of engineering fundamentals with strong problem solving and analytical skills.
• A keen eye for identifying project risks and proactively developing mitigation plans.
• Self‑driver with proven track record of actively engaging and working in a matrixed environment with cross‑functional teams, strong decision making, and completing quality deliverables on time.

Benefits

• 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 (EEDI) – 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.

Have questions? Email [e-mail] – I look 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