Sr Principal Eng, Process Engineering

Johnson & Johnson • Athens, GA

2d • Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Process Engineering Job Category: Scientific/Technology All Job Posting Locations: Athens, Georgia, United States of America Job Description: 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 at https://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.

Requirements

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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior