Distinguished Process Engineer - Aseptic DP

Johnson & Johnson is seeking a Distinguished Process Engineer - Aseptic DP. This position is an industry-leading technical authority in aseptic drug product biotherapeutic manufacturing (compounding, filtration, filling, and automated visual inspection). The role provides technical mentorship to project teams and work groups, offering overarching leadership in implementing new technologies, recommending improvements to enhance engineering and manufacturing efficiency, and evaluating and adapting new technologies.

It also drives the development of technical standards ensuring seamless integration of new technology and engineering standards across multiple sites and cultivates future talent by mentoring internal engineers and encouraging a culture of aseptic engineering excellence.

• Leads the execution of engineering projects and initiatives ($1-$20M range) across multiple sites.
• Leads project team members during project execution.
• Oversees multiple outside vendors and contractors.
• Accountable for sophisticated engineering design and construction solutions delivery for manufacturing facilities, systems, equipment (compounding, filtration, filling, automated visual inspection).
• Proactively researches and implements new technologies to drive business growth and efficiency.
• Stays on top of industry trends through continued education & participation in seminars / trade shows.
• Spearheads the identification and development of new engineering standards for advanced technologies across the network.
• Collaborates with Manufacturing Technology, Environmental and Health Safety, Engineering and Property Services, Quality Assurance, Sterility Assurance, Network Strategy, and Operations to ensure alignment with technology evaluation and technical standards.
• Offers technical support for Global Business Development by leading technical assessments for L&A (license/acquisition)/M&A (merger/acquisition) business development opportunities.
• Assesses network capabilities and strategic planning capacity across the platform.
• Provides technical expertise and mentorship, ensuring compliance with policies, procedures, government regulations, and customer specifications.
• Provides technical support to both the internal and external (CMO) Biotherapeutic and Synthetic aseptic drug product network to solve sophisticated technical engineering and manufacturing problems.
• Cultivates a culture of technical excellence, partnership, and innovation to enable multi-functional learning and standard methodology sharing.
• Develops and mentors engineering team members to ensure a strong talent pipeline.
• Regularly updates senior management on project status, costs, and performance against targets.

• 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.
• Understanding of 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.
• Ability to balance multiple priorities, maintain confidentiality, and communicate and operate with poise and integrity in a sophisticated, high‑profile, and evolving environment.
• Track record of developing and maintaining strong partnerships at all levels within the organization, including key stakeholders.
• Ability to travel 30% (both internationally and within Europe).

• Agile…