Engineer MSAT Validation, Aseptic fill & finish

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

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Job Description:

J&J Innovative Medicine, a member of the Johnson & Johnson Family of Companies is recruiting for an Engineer MSAT to be based in Leiden/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 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:

• Assess, plan and coordinate execution of 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 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.
• As 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.)
  

Minimum Qualification and Requirements

• Bachelor’s, Master’s degree in Science, Engineering or Technical subject
• 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 in the (bio)pharmaceutical industry or related academic experience or education
• Experience or knowledge in qualification in sterile processes (e.g. bio-decontamination, airflow pattern visualization and aseptic process simulation)
• 6-Sigma/Lean or similar continuous improvement methodology experience.
  

J&J Innovative Medicine in Leiden/Sassenheim, the Netherlands, is a leading site for commercial & clinical manufacturing in the dynamic business of Biotherapeutics and Advance Therapeutic Medicinal Products.

We combine our proven strengths with innovation to meet the needs of today and tomorrow. At J&J Innovative Medicine, enthusiastic people are working together in a dynamic culture where innovation and driven mentality are common good. We are proud of our Credo values and our diverse environment and contribute to the highest safety, quality, and sustainability standards. The site and portfolio are growing rapidly which transforms the way we support our patients. Together, we strive for a future in which disease is a thing of the past.

Passionate about our mission? Join our team. Make your mark!

Your development is key to us, and we consider it our day-to-day responsibility. We believe we can make a difference together and take your career seriously. Through on-the-job and development training, assignment to projects and programs, we are committed to your personal and professional growth. Via multiple employee benefits, our company offers support for you and your family now and in the future.

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