Senior Engineer MSAT LM Validation
Janssen Biologics B.V. is recruiting for a Senior Engineer MSAT LM Validation to be located in Leiden, the Netherlands.
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/.
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.
Our Biologics site in Leiden produces biotherapeutic drug substance and is growing our portfolio to include novel advance therapeutic medicinal products.
The Manufacturing Science & Technology (MSAT) department is the leading partner in supporting process validation (SPV), technical product ownership and key driver of sophisticated technologies to enable the best value for patients.
The Senior Engineer is a member of the MSAT-SPV Team with the dedicated focus on:
- Validation of Supporting Processes (e.g. cleaning, mixing, sterilization, thermal)
- Process improvements, benchmarking and standardization.
- New technology deployment.
Job Duties and Responsibilities:
- Assess, plan and coordinate execution of SPV activities such as qualification of cleaning, sterilization, and mixing processes.
- Support projects as a core team member responsible for qualification activities providing regular status updates in a timely manner.
- Act as SME for one or more validation categories. Leverage global MSAT network to identify and implement best practices.
- Act as a mentor or coach for more junior engineers
- Support the department's perpetual audit readiness initiative and represent MSAT in audits and inspections
- Support the site change control program by performing validation impact assessments delivering the resulting implementation plan.
- Maintain compliance with all company policies and procedures (e.g., Quality, EH&S, Business, Credo etc.)