Sr Principal Eng, Process Engineering

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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 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 highperforming 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 earlyphase 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 fitforpurpose 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 inspectionready and compliant

• Drive the adoption of digital and dataenabled solutions for API manufacturing including realtime 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 bestpractice 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 speedtomarket 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/solidstate 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 highimpact programs including API CMOs intermediates and critical raw material processes

Qualifications

Education:

• Minimum of a Masters 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 solidstate/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 scaleup 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 enduse modalities (e.g. APIs for OSD and sterile/lowbioburden 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 earlyphase 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 handson technical capability

• Intellectual curiosity to challenge the status quo influence without authority and cultivate an inclusive and collaborative culture

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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