About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way!

Learn more athttps://www.jnj.com/innovative-medicine

We are searching for the best talent for a Senior Principal Engineer, Process Engineering to join our Team! This is an onsite/hybrid role.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to align with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Belgium - Requisition Number: R-071729

Athens, GA, USA - Requisition Number: R-075187

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Position Summary

As the GET PE – Synthetics Drug Substance (API) Manufacturing Senior Principal Engineer, you will lead early design inputs and technical strategy for synthetic drug substance (API) manufacturing processes within strategic capital projects, network studies, and technology platforms across IMSC. You will provide technical expertise in synthetics API unit operations including chemical reaction, phase separations, distillation/solvent swap, crystallization/precipitation, filtration/centrifugation, drying, milling, blending, etc, while supporting solving and optimization activities at internal and external manufacturing sites.

Joining our global engineering group, you will collaborate with high‑performing, multi-functional teams across multiple sites and functions. This role offers a dynamic and inspiring work environment with significant opportunities to influence API technology direction, standardization, and capability building across the network.

Responsibilities and impact you will have:

Lead the intake, scoping, prioritization, and resolution of synthetics drug substance (API) manufacturing technical requests across global sites
Lead and influence early‑phase process design and act as domain expert for synthetics API processes, from technology and unit operation selection through scope definition and capital and schedule development
Provide technical expertise in critical API unit operations and enabling technologies (e.g., hazardous chemistry, reactions, crystallization, filtration/centrifugation, drying, and particle engineering), with a strong emphasis on product quality, process safety, and robustness
Ensure robust, fit‑for‑purpose process design while promoting standardization and platform approaches (e.g., common reactor trains, filtration/drying trains, solvent recovery concepts) where they make valuable contributions
Ensure API cGMP standards are applied consistently and proactively assess emerging regulatory expectations and industry trends to keep API manufacturing solutions inspection‑ready and compliant
Drive the adoption of digital and data‑enabled solutions for API manufacturing, including real‑time monitoring, advanced process control, advanced data analytics, model and simulation, and smart manufacturing use cases where they improve reliability and performance
Provide expert input and alignment on key process equipment, and technology selection decisions for API manufacturing (e.g., reactors, filters/centrifuges, dryers, contained transfer, solvent recovery, CIP/SIP where applicable)
Actively collaborate with other functions such as R&D/CMC, MSAT, Quality, EHS, and Operations leads across synthetic API sites to enable reliable technical solutions and fast decision making
Find opportunities for harmonization, shared solutions, and best‑practice exchange across the network (e.g., containment standards, process safety approaches, cleaning strategies, etc)
Foster a culture of collaboration to reduce duplication, accelerate implementation, and improve speed‑to‑market for API process and equipment solutions
Maintain strong connections with industry experts and external networks (e.g., ISPE) to bring innovative API manufacturing and particle/solid‑state solutions into the organization
Ensure alignment with enterprise strategies, API GMP requirements (e.g., ICH Q7 as applicable), and technology roadmaps
Collaborate with External Manufacturing teams to prioritize support and resolve issues for high‑impact programs, including API CMOs, intermediates, and critical raw material processes

Qualifications

Education:

Minimum of a Master’s degree or equivalent experience in Engineering, Pharmaceutical Sciences, or a related technical field is required

Experience and Skills:

Required:

Minimum 10 years of relevant experience in synthetics drug substance (API) manufacturing within pharmaceutical (or closely related) manufacturing environments, with strong knowledge of chemical synthesis and API isolation/purification unit operations
Demonstrated expertise in API purification and solid‑state/particle engineering, including crystallization, filtration/centrifugation, drying, milling, and the impact of these steps on quality attributes (e.g., polymorph form, PSD, residual solvents, impurities)
Proven experience with API scale‑up, technology transfer, and process fixing across pilot to commercial scale, including understanding of reactor systems, solvent handling, and process analytical/controls as applicable
Strong understanding of cGMP environments and regulatory expectations for API manufacturing across multiple end‑use modalities (e.g., APIs for OSD and sterile/low‑bioburden drug products), including data integrity and documentation practices. Experience with process safety (e.g., thermal hazard evaluation) and containment for potent compounds is a plus
Proven track record of leading multi-functional teams and influencing technical decisions in complex, global organizations
Digital mentality with experience employing manufacturing data and systems (e.g., PI/data historians) to enable continuous improvement in API operations and adoption of smart manufacturing
Ability to support early‑phase design through detailed design of API manufacturing equipment and facilities (e.g., reactors, centrifuges/filters, dryers, milling, contained transfer, solvent recovery, and supporting utilities)
Proficiency in written and spoken English; additional languages (Dutch, Spanish, Italian) are an advantage
Willingness to travel up to 25% domestically and internationally

Preferred:

Experience with inherently safe containment design for potent materials, including contained charging/transfer, dust control, and exposure mitigation
Strong customer management and communication skills, with the ability to influence across sites, functions, and external partners
Strategic perspective combined with hands‑on technical capability
Intellectual curiosity to challenge the status quo, influence without authority, and cultivate an inclusive and collaborative culture

Required Skills:

Agile Decision Making
Coaching
Consulting
Corrective and Preventive Action (CAPA)
Crisis Management
Cross-Functional Collaboration
Disruptive Innovations
Emerging Technologies
Industrial Hygiene
Lean Supply Chain Management
Process Control
Process Engineering
Product Costing
Program Management
Project Schedule
Science, Technology, Engineering, and Math (STEM) Application
Tactical Planning
Technical Credibility
Technical Research

Preferred Skills:

Agile Decision Making
Coaching
Consulting
Corrective and Preventive Action (CAPA)
Crisis Management
Cross-Functional Collaboration
Disruptive Innovations
Emerging Technologies
Industrial Hygiene
Lean Supply Chain Management
Process Control
Process Engineering
Product Costing
Program Management
Project Schedule
Science, Technology, Engineering, and Math (STEM) Application
Tactical Planning
Technical Credibility
Technical Research

Sr Principal Eng, Process Engineering

About the role