Job Summary

The job holder will be part of the global SME West Internal Testing team supporting the development, optimization, and validation of methods for release testing and in-process control. She will work in tight cooperation with international team members to implement the developed methods, train users and support the laboratory teams in various sites across the globe.

As part of the global SME West Internal Testing team the job holder will support and contribute to global laboratory joint projects. She will own small and mid-size global projects including project planning, tracking, reporting and communication.

Essential Duties and Responsibilities

• Following all relevant ESOPs, SOIs, PFNBs etc. according to company policy and cGMP regulated environment.
• Project planning, progress tracking, reporting and communication of small and mid-size projects.
• Authoring and execution of lab study protocols for method development projects in combination with independent data analysis of experimental results.
• Authoring and execution of validation protocols, qualification protocols of computerized inspection systems as well as PNRs.
• Authoring, execution and documentation of inter-laboratory studies.
• Providing training for trainers for newly implemented global test methods and technologies.
• Performing literature searches such as compendial and regulatory guidelines, scientific publications, state-of-the-art equipment, or any project relevant information.
• Assisting the SMEs in investigating deviations / out of spec incidents for the global laboratory network.
• Supporting implementation of global change controls.
• Compliance with all safety relevant regulations.

Education

• Minimum: Bachelor’s degree in Natural Sciences or equivalent experience

Work Experience

• At least 3 years hands-on working experience in a laboratory.
• Experience in operating state-of-the-art laboratory equipment.
• appropriate capability to work inthe laboratory and execute microscopic evaluation potentially for several hours (mandatory).
• willingness to work in clean rooms (up to ISO 5)

Preferred Knowledge, Skills and Abilities

• Fluent in English & German (written and spoken)
• Ability to collaborate and effectively work in a team
• Advanced project management skills
• In-depth experimental skills for selected testing routines
• Strong mindset for project ownership and clear motivation to drive projects forward
• Excellent GMP compliant documentation skills
• Very good verbal and written presentation and communication skills
• Structured and independent way of working
• Thinking outside the box attitude
• Enjoy constructive discussions with a clear technical focus on the subject
• Solution-oriented and problem-solving mentality
• Willingness to learn and develop
• Flexibility and willingness to work early or late shifts as dictated by projects and business needs
• Good experimental and lab oriented organizational skills
• Safe handling of measurement technologies/techniques
• Reliability, diligence, and flexibility
• Experience in Microsoft office software package
• Experience in SAP and Minitab would be a plus #LI-JJ1

Travel Requirements

Physical Requirements

Additional Requirements

• Job-related activities that require a physical activity such as standing in laboratory environment
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms.
• Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures)

What We Offer