Senior Plant System Engineer

Johnson & Johnson•Spring House, PA

6d•Hybrid

About The Position

At J&J IM we are an R&D focused organization striving to improve life and medical outcomes for millions of patients worldwide. If you want to be a true pioneer and advance the use of data to lead our journey towards the development of innovative therapeutics, then seize this opportunity and join our team! Within the Digital Operations & Strategy (DOS) department of Therapeutics Development & Supply (TDS) we harness the power of data, technology, predictive modeling, and informatics to inform decisions. We aim to enable a digital enabled organization that speeds up life-saving treatment development. Our Plant Systems team has responsibility for developing and implementing systems strategies for the R&D development API and Drug Product pilot plants, in support of process development, manufacturing, tech transfer and lifecycle management, in close partnership with the development functions and IT. As a key member of the Business System Ownership team, the Senior Plant Systems Engineer will drive the strategy and implementation of manufacturing systems in the Therapeutics Development & Supply (TDS) pilot plants in close collaboration with the pilot plant leadership. The TDS pilot plants (spanning Synthetics, Advanced Therapies, and Proteins) play a pivotal role in the development of new medicines, from lab scale to pilot and clinical scale, to commercial scale manufacturing. The successful candidate will be a proactive and effective problem solver who is intellectually curious and has a proven track record of implementation of manufacturing systems in life sciences.

Requirements

Bachelor’s degree or higher in Chemical Engineering, Chemistry, Pharma, Information Technology or related sciences/engineering disciplines is required.
Minimum of 6+ years of relevant industry experience in pharmaceutical, biotech, or related sectors is required.
Hands-on experience with MES (Körber PAS-X), Historian (AVEVA-PI), or Advanced analytics (SEEQ) in manufacturing environments is required.
Thorough knowledge of ISA S88/S95 standards is required.
Hands-on experience with advanced data analytics relevant to pharmaceutical development (at least two of the following areas): plant systems, process analytics, or digital tools is required.
Demonstrated knowledge of Good Manufacturing Practice (GMP) regulations; proven understanding of GAMP and SDLC requirements is required.
Organizational and project management skills, balancing multiple complex projects with effective customer management is preferred.
Strong passion for digital transformation and innovation
Ability to thrive in a fast-paced, dynamic environment that values agility, precision, and creative problem-solving.
Excellent interpersonal and communication skills, capable of influencing diverse audiences and fostering collaboration.
Strategic thinker with personal leadership skills, attention to detail, and a track record of effective cross-functional teamwork.
Proven problem-solving abilities, translating complex concepts into actionable solutions.
Global, end-to-end attitude.
Fluency in English required.

Nice To Haves

Experience with PLC-controlled equipment, process automation hardware and software, OT networks infrastructure and systems is highly preferred.
Commissioning/qualification/validation experience is preferred.
Proven experience with the drug development process, including tech transfer and product lifecycle management is preferred.
Experience with FAIR data principles and digital transformation projects is preferred.
Experience leading cross-functional projects and inspiring teams toward shared goals is preferred.
Limited travel (<10%).

Responsibilities

Design & Implement Software Solutions : Together with functional business leaders, data architects and IT, define future state plant systems landscape for the TDS pilot plants (MES, PI and Seeq), driven by business value
Data Lifecycle Management : Have a solid understanding of the entire data process for the plant systems (systems (MES, PI and Seeq)) from collection to analysis, adhering to FAIR (Findable, Accessible, Interoperable, Reusable) data principles.
Collaborate with Scientific Experts : Partner with scientists, engineers, and IT teams to optimize manufacturing systems, ensuring seamless data integration and usability.
Stakeholder Alignment : Work closely with TDS stakeholders to align strategies, prioritize system enhancements, and promote widespread adoption of data solutions.
Vendor Management : Manage relationships with vendors of laboratory, manufacturing, and data analytics systems to ensure quality, compliance, and innovation.
Troubleshooting & Continuous Improvement : Identify and resolve system and data issues, proposing both immediate fixes and long-term improvements.
Regulatory, Audit & SOP Management Support: Represent business user requirements during system upgrades, validations, and regulatory inspections to ensure compliance, data integrity, and operational excellence. Own and coordinate SOP lifecycle management for relevant manufacturing systems, ensuring procedures remain aligned with the validated system state. Ensure robust support and incident management processes are in place, safeguarding continuous compliance and maintaining the validated state of manufacturing systems, under the leadership of the Plant Systems Business Owner.
Cross-Functional Leadership: Lead or contribute to projects across departments, fostering collaboration and innovation. Drive adoption and business value realization of systems and data.
Business value realization: Drive adoption and business value realization of systems and data.
Connect: Actively network within the industry and enterprise supply chain to proactively benchmark, exchange knowledge and bring in best practices.