Distinguished Process Engineer - Aseptic Dp

Johnson & Johnson Johnson & Johnson · Pharma · Schaffhausen, Switzerland

Distinguished Process Engineer with 15 years of experience in aseptic drug product biotherapeutic manufacturing, focusing on compounding, filtration, filling, and automated visual inspection. This role involves technical leadership, mentoring, implementing new technologies, and developing technical standards across multiple sites, ensuring compliance with cGMP and regulatory bodies.

What you'd actually do

  1. Leads the execution of engineering projects and initiatives ($1-$20M range) across multiple sites. Leads project team members during project execution. Overseas multiple outside vendors and contractors.
  2. Accountable for sophisticated engineering design and construction solutions delivery for manufacturing facilities, systems, equipment (compounding, filtration, filling, automated visual inspection).
  3. Proactively research and implement new technologies to drive business growth and efficiency.
  4. Staying on top of industry trends through continued education & participation in seminars / trade shows
  5. Spearhead the identification and development of new engineering standards for advanced technologies across the network.

Skills

Required

  • Bachelor of Science in Engineering; Chemical or Mechanical preferred; Master of Science in Engineering preferred.
  • 15 years of experience in a drug product Biotherapeutics engineering role.
  • Fluent in written and spoken German and English
  • cGMP’s for aseptic manufacturing of multiple regulatory bodies (EU, FDA), including fluency in the understanding of new EU Annex 1 guidelines and its impact on facility/equipment design
  • Hands-on experience in the C&Q (commissioning and qualification) of Biotherapeutic aseptic drug product process equipment (compounding, filtration, filling, and automated visual inspection).
  • Ability to synthesize strategies, business needs, engineering elements, and technology inputs into data driven business solutions. Drive innovation and forward thinking for cGMP compliance
  • Strong problem solving, communication, and decision-making skills to drive impact in a fast-paced evolving business landscape including highly sophisticated technical problems
  • Able to balance multiple priorities, maintain confidentiality, and communicate and operate with poise and integrity in a sophisticated, high-profile, and evolving environment is required.
  • Track record of developing and maintaining strong partnerships at all levels within the organization, including key stakeholders.
  • Develop and mentor engineering team members to ensure a strong talent pipeline.
  • Ability to travel 30% (both internationally and within Europe)

What the JD emphasized

  • aseptic drug product biotherapeutic manufactuirng
  • cGMP’s for aseptic manufacturing of multiple regulatory bodies (EU, FDA), including fluency in the understanding of new EU Annex 1 guidelines