Job Information
J&J Family of Companies Senior Principal Engineer, Aseptic Manufacturing in Schaffhausen, Switzerland
Senior Principal Engineer, Aseptic Manufacturing - 2406207971W
Description
Johnson & Johnson Innovative Medicine are recruiting for a Sr. Principal Engineer Aseptic Manufacturing to be based in Schaffhausen, Switzerland or Beerse, Belgium.
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 worlds 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.
As a Sr. Principal Engineer reporting into the MSAT LM Cross Platform Engineering group, you will hold a strategic and tactical role within Global MSAT and will partner with R&D, Make functions, New Product Introduction, the Quality Organization, Microbiological Quality and Sterility Assurance and Value Chain Management teams, as well as internal manufacturing sites, external partners, such as contract manufacturing organizations, to develop and implement robust manufacturing processes.
You will team-up to deliver short-to-long term pipeline of initiatives associated to Johnson & Johnson large molecule and parenteral product strategy and grow.
Key Responsibilities:
Single Point of Contact (SPOC) for MSAT needs for LM and parenteral products with regard to aseptic manufacturing processes and applicable validations.
In conjunction with other key disciplines to develop and deploy a JJIM enterprise methodology on a Gravel-to-Grave process on robust aseptic manufacturing.
Perform as a knowledgeable subject matter expert (SME) for the aseptic operations at JJIM supply chain.
Manage a community of practices and know-how around aseptic manufacturing within the firm.
Proactively promote quality and compliance in the areas of sterile manufacturing and its validation and coach others to do the same.
Oversee technical support to regulatory filings, regulatory inspections, and health authority questions.
Collaboration in technology transfer projects supporting implementation of new processes in manufacturing operations.
Initiate and review of aseptic manufacturing documentation (SOPs, etc) to ensure they are current, accurate, and clear.
Qualifications
Strong expertise on pharmaceutical manufacturing processes and products, equipment with focus on low bio-burden and sterile manufacturing
Strong knowledge of Quality & Compliance / regulatory requirements (GMP) especially for sterile manufacturing.
Ability to manage complexity and change
Ability to interact at different levels of the organization.
Ability to work under pressure, handle conflicting interests, and take decisions
Customer and business focus, team player
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Primary Location Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen
Other Locations Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization Cilag GmbH International (8525)
Job Function Technology Operations Support
Req ID: 2406207971W