Description
At Johnson & Johnson Innovative Medicine, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Are you ready to be part of something groundbreaking? Do you want to make a real impact on patient lives? Are you passionate about innovation and teamwork? If the answer to these questions is yes, we are looking for you!
The Quality Control Development (QCD) group is recruiting for an Expert Technician Microbiology, located in Leiden, The Netherlands. QCD is part of the Analytical Development (AD) Department of the Advanced Therapeutics sector of J&J Innovative medicine and is responsible for a wide range of activities to support production of our new Advanced Therapeutics clinical products. These responsibilities include: coordination and execution of release and stability testing, sample management, raw material release, change management, cell culture services, and assessing the controlled state of the clean rooms and utilities of the Advanced Therapeutic Production (ATP) facility. The QCD group is a complementary team with different nationalities and backgrounds, working closely together in an international environment.
Job description
The Expert Technician Microbiology role is available within the Microbiology team and performs routine tasks with limited supervision and more sophisticated tasks with support. Their focus is on performing impact assessments and documentation activities for environmental and utility monitoring to support the production of our new Advanced Therapeutic products in the ATP facility.
We are looking for an expert technician with extensive experience in Microbiology and cGMP, who enjoys working in a multidisciplinary environment with different collaborators.
Key responsibilities:
- Comprehensive assessment of the impact of changes in the ATP facility on the monitoring program with support of the Microbiology SME
- Author and review (re)qualification protocols and reports, and perform critical evaluation of clean room and utility monitoring trending data
- Effective stakeholder management and building strong relationships with collaborators
- Perform laboratory investigations and accurate documentation of nonconformances in the quality system, ensuring that a high level of Quality is maintained within the department
- Support Microbiology laboratory operations by performing data review, assisting in coordination of lab activities and providing guidance to Microbiology team members for non-routine tasks
- Participate in continuous improvement projects that progresses the department in quality, EHS and efficiency gain with a large focus on digitalization.
Qualifications
Qualifications
Education:
- A minimum of a B(A)Sc degree in Microbiology or related field.
Experience and Skills:
Required:
- At least 5 years of work experience in similar or related role.
- Demonstrated in-depth knowledge of applicable EU GMP, EP, USP and ISO guidelines
- Extensive experience within a cGMP and a Quality driven environment.
- Excellent organizational capabilities and ability to maintain overview
- Ability to identify areas of improvement and optimize processes in a dynamic and growing environment
- Teammate with well-developed interpersonal skills and capable of maintaining positive relationships.
- Positive and proactive mentality, enthusiastic and motivated
- Good communication in English and Dutch (written and verbally).
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 on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.