Quality Lab Scientist (m/w/d) 1 Jahr befristet

Johnson & Johnson Medical Devices, a member of the Johnson & Johnson family of companies is recruiting for the office in Norderstedt, Germany a:

QUALITY LAB SCIENTIST (M/F/D) 1 JAHR BEFRISTET

Location: Norderstedt

The Quality Lab Scientist is responsible for executing and supporting the implementation of business improvement initiatives for Quality Operations Laboratories. He or she defines opportunities, analyzes data with cross functional partners and implements improvements. He or she ensures compliance to JNJ and international Standards applicable to area of responsibility and drives forward the state-of-the-art direction and best practices.

YOUR TASKS & RESPONSIBILITIES:

• Collaborate in Quality Operation Projects to plan, prepare, execute and/or support equipment qualification, test methods validation or computer system validation complying with local and global regulatory requirements as well as J&J standards
• Support Compliance Projects and implements actions which result from new standards, Non-Conformances, Audits or CAPAs
• Support and initiate Quality Operation Projects including but not limited to: Cost Improvement, System Changes, LEAN, New Software Systems, etc.
• Develop expert level of knowledge for LIMS and use it for implementation or establishment of compliance or business/process improvement
• Perform in and support Change Management Processes
• Assist the Quality Lab Scientist Supervisor in establishing the QO Laboratories projects and initiatives
• Support the Quality Lab Scientist Supervisor and other Lab Supervisors in developing, coordinating and implementing projects for improvement of processes
• Implement and establish Data Integrity for the QO Laboratory Equipment complying with regulatory requirements as well as J&J standards
• Supports facility management in clean room qualifications
• Responsible for microbiological test methods and execution
• Supports the Quality Lab Scientist Supervisor in maintenance of the environmental monitoring program (analysis of significant quality trends, report of conclusions for e.g. risk based decisions) and microbial release
• Assists the team in assessment of nonconformances, out of trend, out of spec events, develops solutions, and supports product dispositions

EDUCATION AND/OR EXPERIENCE:

Education:

• University/ Bachelor’s Degree or Equivalent in a Life Science or Engineering
• Advajnced computer skills and use of software applications

Experience and Skills:

Required:

• German, fluent, native language preferred. English, fluent
• Demonstrated project management abilities
• Proficient in Microsoft Office —Word, Excel, and PowerPoint
• A thorough understanding of GMP (Good Manufacturing Practices)/ISO (International

Organization for Standardization) regulations

• Experience in microbiology and GMP related topics
• Accurate and independent working methodology
• Analytical and methodical problem solving
• Good communication skills and team experience

Preferred:

• Knowledge of regulatory requirements (MPG, MDD, 21CFR820, ISO 13485)
• Knowledge of room qualifications and method/device validation
• 3-5 years’ work experience in GxP regulated industry
• Experience in change management

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Germany are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Severely disabled applicants will be given special consideration if they are equally qualified.