Job Description
Johnson & Johnson is seeking a Sr 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, including compounding, filtration, filling, and automated visual inspection. The role provides technical expertise to project teams and workgroups, leading the implementation of new technologies, recommending improvements to enhance efficiency, and evaluating and adapting new technologies. The engineer helps develop technical standards and ensures seamless integration of new technology and engineering standards across multiple sites, fostering a culture of aseptic engineering excellence.
Key Responsibilities
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 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.
Provide technical support for Global Business Development by leading technical assessments for L&A (license/acquisition) and M&A (merger/acquisition) opportunities.
Assess network capabilities and strategic planning capacity across the platform.
Proactively research and implement new technologies to drive business growth and efficiency.
Stay current on industry trends through benchmarking.
Lead the business case development and engineering design through the concept phase, capital approval, 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
Minimum of a Bachelor’s degree in Engineering; Master’s or MBA preferred.
At least 10 years of process engineering and capital execution experience in a biotherapeutic aseptic drug product manufacturing environment.
Hands‑on experience in commissioning and qualification of biotherapeutic aseptic drug product process equipment.
Ability to synthesize strategies, business needs, engineering elements, and technology inputs into data‑driven business solutions.
Large capital project management experience in the range of $1 million to $20 million (preferred).
Ability to balance multiple priorities, maintain confidentiality, and communicate with poise and integrity in a sophisticated, high‑profile environment.
Track record of developing and maintaining strong partnerships at all levels within the organization, including key stakeholders.
Understanding of complex technical and regulatory issues impacting facility equipment design.
Fluent in written and spoken German and English; fluency in Dutch is a plus.
Required 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 their impact on facility/equipment design.
Principles of engineering design for drug products in the biotherapeutic industry.
Strong technical process understanding, knowledge, and 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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