Description
Change lives for the better.
At Johnson & Johnson, 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/.
THE OPPORTUNITY
The Research & Development group of J&J Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases, cardiovascular and metabolism, and pulmonary hypertension.
The Drug Substance Development department in Leiden focuses on advanced therapies, a novel class of medical products that uses cell and gene therapies which have the potential to cure diseases where no treatment is currently available. It's a very exciting field, as no established manufacturing platforms exist for these products. That means that new processes need to be developed to ensure high-quality and efficient production of GMP material!
The Technical QA team is part of the Quality Assurance department at Janssen Vaccines & Prevention in Leiden which is transitioning to support advanced therapies. The QA team is responsible for overseeing and supporting the quality systems, projects and facilities. The work of QA to shape and deliver the right quality is key for the success of Janssen V&P. You will ensure that the foundation is in place on which new products will be developed! The group is forward looking, working on improving processes, being customer focused and supports the need for speed.
We are recruiting a Sr. QA Associate Technical QA to join our QA team. We are seeking a highly motivated and independent individual who will be overseeing all aspects of the qualification and validation of equipment, utilities, and environmental conditions in our pilot plant and QC laboratories.
Key responsibilities:
- Perform QA oversight over equipment qualification, clean water and clean air systems and the associated clean rooms (including grade A areas) which are used for GMP biotechnological manufacturing.
- Support the management of quality incidents, corrective and preventive actions, and change controls.
- Represents Quality on cross-functional teams and participates in site initiatives and projects.
- Applies quality, scientific and engineering principles for problem solving and advise to the teams.
Qualifications
IT’S ALL ABOUT YOU
To be successful, you demonstrate the ability to communicate effectively at all levels within a virtual matrix environment. Further requirements include:
- BSc or equivalent experience with 2-5 years or MSc or equivalent experience with 0-2 years of Pharma/biotech industry experience.
- Good understanding of regulatory requirements and industry best practices for equipment qualification, aseptic processing, clean rooms and clean water systems.
- Understanding of GMP data integrity requirements.
- Strong connecting and teamwork skills.
- Strong communication skills in English.
Are you ready to make an impact?
If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.
We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.
Closing date: Tuesday, 4th of February 2025.
Being part of Johnson & Johnson can change everything, including YOU
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.