Johnson & Johnson
Validation Engineer MSAT
MSAT Validation Engineer
Location: Sassenheim
Hours: 40 hrs onsite
Start Date: Ideally September - 6 months contract assignment
Essential: Experience within - Validation of supporting processes (e.g. mixing, sterilization, thermal, bio-decontamination, Aseptic process simulation
The Department:
J&J Innovative Medicine, a member of the Johnson & Johnson Family of Companies, is recruiting for an Engineer MSAT to be based in Sassenheim, the Netherlands. Our site produces biotherapeutic drug substance and is growing our portfolio to include novel advanced 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 Role:
The Engineer is a member of the MSAT SPV Team with the dedicated focus on:
Validation of supporting processes (e.g. mixing, sterilization, thermal, bio-decontamination).
Aseptic process simulation.
Airflow pattern visualization (smoke studies).
Process improvements, benchmarking and standardization.
New technology deployment.
Job Duties and Responsibilities:
Plan, coordinate and execute SPV activities such as qualification of sterilization, mixing, bio-decontamination processes.
Assess, plan and coordinate execution of airflow pattern visualization and Aseptic Process Simulations.
Support projects as project team member responsible for qualification activities providing regular status updates in a timely manner.
Support execution of activities for audit/inspection readiness.
Maintain compliance with all company policies and procedures (e.g., Quality, EH&S, Business, Credo etc.)
Minimum Qualification and Requirements
Bachelor’s degree or equivalent in Science, Engineering or Technical subject
Minimum 2 years of relevant experience in the (bio)pharmaceutical industry or related academic experience or education is required.
Skills in communication, planning, documentation practices, risk management, root cause problem solving and knowledge management.
Understanding of regulatory requirements and industry guidelines specific to the pharmaceutical industry and validation (e.g. FDA, EMA, ICH, ASTM, ISO, ISPE, PDA etc.)
Preferred:
Experience or knowledge in sterile processes qualification (e.g. bio-decontamination, air flow pattern visualization and aseptic process simulation)
6-Sigma/Lean or similar continuous improvement methodology experience.
Benefits
This role offers a competitive hourly rate & a supportive working environment.
About Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.
For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.
https://www.jnj.com/healthcare-products/medtech
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. Please apply via the link.
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”.