Sr Principal Process Engineer Aseptic DP

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Johnson & Johnson is seeking aSr Principal Process Engineer - Aseptic DP.

As part of the Global Process Engineering Team the Sr. Principal Process Engineer Aseptic DP is an authority (SME) in aseptic drug product Biotherapeutic manufacturing (compounding filtration filling and automated visual inspection). They provide technical expertise to project teams and workgroups offering leadership in implementing new technologies recommending improvements to enhance efficiency and the evaluation and adaptation of new technologies. This role also involves the development of technical standards and ensuring seamless integration of new technology and engineering standards across multiple sites. This role will play a significant role in encouraging a culture of aseptic engineering excellence.

Key responsibilities include:

• Accountable for the delivery of sophisticated engineering design and construction solutions for manufacturing facilities systems and equipment. (compounding filtration filling and automated visual inspection).
• Support the discovery and development of new engineering standards for sophisticated technologies across the network.
• Collaborate with the Manufacturing Technology (MSAT) Environmental and Health Safety Engineering and Property Services Quality Assurance Sterility Assurance Network Strategy Automation 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.
• Proactively research and implement new technologies to drive business growth and efficiency.
• Stay on top of industry trends through benchmarking.
• Lead the business case development and engineering design through the concept phase/capital approval of capital project appropriations and process improvement projects.
• Regularly update senior management on project status costs and performance against targets.
• Ensure detailed documentation of all engineering activities.
• 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.
  

Qualifications

• A minimum of a Bachelors degree in Engineering is required. Masters/MBA preferred.
• A minimum of 10 years of process engineering and capital execution experience in a Biotherapeutic aseptic drug product manufacturing environment.
• Hands-on experience in the C&Q (commissioning and qualification) of Biotherapeutic aseptic drug product process equipment (compounding filtration filling and automated visual inspection) is required.
• Ability to synthesize strategies business needs engineering elements and technology inputs into data driven business solutions is required.
• Large capital project management experience in the range of $1 million to $20 million is required (preferred).
• Ability to synthesize strategies business needs engineering elements and technology inputs into data driven business solutions is required.
• 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.
• Understanding complex technical/regulatory issues impacting facility equipment design.
• Must be fluent in written and spoken German and English. Fluency in Dutch is a plus.
• The position requires a minimum of 20% domestic travel and international travel; business needs could require up to 50% domestic or international travel.
  

Solid understanding of the following:

• cGMPs 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
• Principles for Engineering Design for drug products in the Biotherapeutic industry
• Strong technical process understanding knowledge and experience and has a phenomenal passion for solving highly sophisticated technical problems
• Strong problem solving communication and decision-making skills to drive impact in a fast-paced evolving business landscape
• Ability to drive process engineering innovation for equipment and facilities ensuring technical knowledge is maintained and expanded throughout the team
  

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.

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