Senior Validation Quality Assurance Associate

Senior QA Associate Technical Validation QA

Location: Leiden, Netherlands - Hybrid working - 3 days a week onsite

Duration: 6 months

Hours: Full time

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 Validation 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.

roles and 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.

how to succeed

Education:

• BSc or equivalent experience with 2-5 years or MSc or equivalent experience with 0-2 years of Pharma/biotech industry experience.

Experience and Skills: 

• Good understanding of regulatory requirements and industry best practices for, equipment qualification, clean rooms, and clean water and gas systems

• Validation experience within pharma/biotech industry 

• Understanding of GMP data integrity requirements 

• Strong connecting and teamwork skills

• Strong communication skills in English

benefits

This role offers a very competitive hourly rate. This contract will run for 6 months. 

you are welcome here

Johnson & Johnson is 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.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email.

The pay rate for this role will depend on how you are paid. 

Diversity, Equity & Inclusion

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 are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each 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”.