Senior Engineer MSAT LM Validation – Johnson and Johnson – Leiden

  • Leiden

Johnson and Johnson

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.) Qualification and Requirements * Bachelor’s degree or higher, in Science, Engineering or Technical subject * Minimum 2 years of relevant experience in the (bio)pharmaceutical industry 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 for the pharmaceutical industry and validation (e.g. FDA, GMP, ICH, ASTM, ISPE, PDA etc.) Preferred: * 6-Sigma/Lean or similar continuous improvement methodology experience. What we offer: J&J Innovative Medicine in Leiden, 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 trainings, 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. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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