Johnson & Johnson
MSAT Engineer
Engineer MSAT Validation
Location: Leiden, the Netherlands
Duration: 1 year
Hours: 40
Imagine your next project driving sophisticated technologies to enable the best value for patients at a growing biotherapeutic drug substance site.
Roles and Responsibilities
The Manufacturing Science & Technology (MSAT) department is the leading partner in supporting process validation, technical product ownership and a key driver of sophisticated technologies. As an Engineer, you will be a member of the MSAT Supporting Process Validation (SPV) Team with a dedicated focus on:
Validation of supporting processes (e.g., cleaning, mixing, sterilization, holding time)
Process improvements, benchmarking, and standardization
New technology deployment
This role will involve:
Planning, coordinating, and executing validation activities such as cleaning validation, mixing validation, sterilization qualification, and holding time studies.
Writing and reviewing validation protocols and reports.
Supporting projects as an extended project team member responsible for validation activities, providing regular status updates.
Communicating with stakeholders to coordinate timing of execution and escalate issues.
Supporting the execution of activities for audit/inspection readiness.
Maintaining compliance with all company policies and procedures (e.g., Quality, EH&S, Business, Credo).
How to succeed
You will bring a Bachelor’s degree or equivalent in a Science, Engineering, or Technical subject with a minimum of 2 years of relevant experience in the (bio)pharmaceutical industry or related academic experience.
Skills in communication, planning, documentation practices, risk management, root cause problem solving, and knowledge management.
An understanding of regulatory requirements and industry guidelines specific to the pharmaceutical industry and validation (e.g., FDA, EMA, ICH, ASTM, ISO, ISPE, PDA).
Experience or knowledge in validation (e.g., cleaning validation, mixing validation, sterilization qualification, holding time studies) is preferred.
Experience with 6-Sigma/Lean or a similar continuous improvement methodology is also preferred.
Benefits
This role offers a very competitive hourly rate. This contract will run for a 12 month
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.
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”.