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 manufactuirng (compounding, filtration, filling, and automated visual inspection). This 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 the evaluation and adaptation of new technologies. This role also drives the development of technical standards ensuring seamless integration of new technology and engineering standards across multiple sites. This role will play a significant role in cultivating future talents by mentoring both internal engineers and encouraging a culture of aseptic engineering excellence.
 

Responsibilities include:

• 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.
• Accountable for sophisticated engineering design and construction solutions delivery for manufacturing facilities, systems, equipment (compounding, filtration, filling, automated visual inspection).
• Proactively research and implement new technologies to drive business growth and efficiency.
• Staying on top of industry trends through continued education & participation in seminars / trade shows
• Spearhead the identification and development of new engineering standards for advanced technologies across the network.
• Collaborate with the 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.
• Offer technical support for Global Business Development by leading technical assessments for L&A (license/acquisition)/M&A (merger/acquisition) business development opportunities.
• Assess network capabilities and strategic planning capacity across the platform.
• Provide technical expertise and mentorship, ensuring compliance with policies, procedures, government regulations, and customer specifications.
• Provide technical support to both the internal and external (CMO) Biotherapeutic and Synthetic aseptic drug product network to solve sophisticated technical engineering and manufacturing problems.
• Cultivate a culture of technical excellence, partnership, and innovation to enable multi-functional learning and standard methodology sharing.
• Develop and mentor engineering team members to ensure a strong talent pipeline.
• Regularly updating senior management on project status, costs, and performance against targets.
   

Required Education:

• Bachelor of Science in Engineering; Chemical or Mechanical preferred; Master of Science in Engineering preferred.
   

Required Experience:

• 15 years of experience in a drug product Biotherapeutics engineering role.
   

Required Knowledge, Skills, and Abilities:

• 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)
  
   

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
 

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.