Staff Project Engineer

Janssen Biotech is seeking a Staff Project Engineer to join the engineering team at the Malvern, PA facility where we make bulk drug substance for both commercial and clinical phase mAb products. This role will be responsible for providing advanced engineering, design, and construction of manufacturing facilities, systems, and equipment; and providing engineering and technical support for complex production and processing equipment. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies. Specifically: • Design and delivery of local and cross site projects • Owns design and commissioning of new equipment or facility renovations • Works with internal experts, engineering firms, and equipment vendors This position primarily supports the Malvern facility. In addition, it supports initiatives across the global large molecule platform. Key Responsibilities: • Lead engineering execution of projects and initiatives in the platform, for strategic projects and across sites. • Generates capital equipment appropriations required for new process implementation or facilities and controls expenditures to ensure compliance with timing and budget requirements. • Ensures attainment of project schedules, budgets, procedures and revenues by developing and monitoring the budget and approval process. • Manages team members during project execution including multiple outside vendors and contractors. Project Management responsibility for projects in the $1-10 million range. • Keeps senior management informed by crafting, maintaining, and presenting written reports on project status, tests, costs, issues, and performance on a regular basis. • Provides technical leadership on teams on projects/ process improvements and resolves inter-functional issues. • Ensures the documentation of project and program activities and deliverables. • Ensures proper system integration by overseeing the development of the systems integration and systems assurance test plans and procedures; reviews test results. • Ensure project compliance with EHS&S policies and procedures. • Coordinate with Technical Operations group to ensure alignment on technical standards and project execution for technical transfer projects/NPI. • Develop and drive engineering standards throughout platform and ensure application of standards at all sites. • Engineering Subject Matter Experts (SME’s) to drive adoption and support projects for standard equipment platforms; train engineers on standards. • Engineering SME's to support project delivery process, C&Q, and FPX standards to drive deployment. Work with E&PS to provide training, maintain, update standards • Researches business and technical issues to establish current state and where improvements are possible. • Maintains professional and technical knowledge by attending educational seminars and trade shows, reviewing professional publications and analyzing new trends. Qualifications Education: This position requires either experience in industry or a combination of education and proven experience: Bachelor's Degree or higher with at least 7+ years’ of related experience. Or a Master’s or PhD with 4+ years’ experience. Experience and Skills: • Consistent track record in Project Engineering in the pharmaceutical industry including design, construction, and commissioning and qualification. • Experience with pharmaceutical equipment, utilities systems, and facilities engineering are an advantage. • The ability to support engineering design of manufacturing equipment and supporting utilities, and being “hands on” with the equipment in the manufacturing facility are beneficial. • Strong interpersonal skills. • Knowledge of GMP water, steam, compressed gasses, and HVAC systems is helpful. • Experience supporting the definition of department, project and/or program goals and tactics, and defining objectives to achieve targets on a team and/or individual level is beneficial. • Prefers building knowledge and expertise in other technical and business functions. • Experience applying collaborative leadership skills and/or leading small cross functional teams to deliver large or small scale projects under limited supervision is preferred. • Extensive contributions to the delivery of projects or the execution of programs and assuming ownership of certain aspects of project or program is preferred. • Experience promoting creative solutions and proposing improvements in processes and/or methodologies is preferred. • High degree of collaboration with internal partners (manufacturing, quality, engineering, etc.) to develop standards and define project needs and priorities; as well as recruiting project team members is preferable. • Interaction with external partners (A&E Firms and construction firms, consulting firms) to remove barriers, clarify roles and responsibilities, and coordinate and implement project plans is preferable. • Experience supporting regulatory inspections is beneficial. • This position supports a manufacturing facility in continuous operation. Responding to emergencies or supporting project implementation outside of normal business hours is required. • Supporting other departments or projects according to business needs is required. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-Pennsylvania-Malvern-200 Great Valley Parkway Organization Janssen Biotech, Inc. (6014) Job Function Engineering Requisition ID 2206021746W