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 .

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.

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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 Sr Principal Eng - 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 & Italy- Requisition Number: R-071736

Puerto Rico - Requisition Number: R-076777

Switzerland - Requisition Number: R-076783

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 Product Manufacturing Senior Principal Engineer you will lead early design inputs and technical strategy for synthetics drug product manufacturing processes within strategic capital projects network studies and technology platforms across IMSC. You will provide deep technical expertise in the synthetics controlled bioburden-drug product manufacturing (OSD and innovative forms such as semi-solid) and drug product intermediate through bioavailability enhanced technologies 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 technology direction standardization and capability building across the network.

Responsibilities and impact you will have:

• Lead the intake scoping prioritization and resolution of synthetics controlled bioburden- drug product manufacturing related technical requests across global sites

• Lead and influence earlyphase process design and domain expertise for oral solid dose (OSD) products covering both batch and continuous manufacturing platforms; as well new innovative drug product forms

• Lead and influence earlyphase process design and domain expertise for bioavailability enhanced technologies including amorphous solid dispersions (ASD) with a strong emphasis on spray drying as well as other technologies such as Self-Emulsifying Drug Delivery Systems (SEDDS) and other related innovative drug product intermediate formulation approaches

• Ensure robust fitforpurpose process design while promoting standardization and platform approaches where they make valuable contributions

• Provide expert input and alignment on key process equipment and technology selection decisions for drug product manufacturing

• Actively collaborate with other functions such as R&D MSAT Quality EHS and Operations leads across synthetic drug product sites

• Find opportunities for harmonization shared solutions and bestpractice exchange across the network

• Foster a culture of collaboration to reduce duplication accelerate implementation and improve speedtomarket

• Maintain strong connections with industry experts and external networks (e.g. ISPE) to bring innovative drug product manufacturing solutions into the organization

• Ensure alignment with enterprise strategies GMP requirements and technology roadmaps

• Collaborate with External Manufacturing teams to prioritize support and resolve issues for highimpact programs and partners

Qualifications

Required:

Education:

• Minimum of a Masters degree or equivalent experience in Engineering Pharmaceutical Sciences or a related technical field is required

Experience and Skills:

• Minimum 10 years of relevant experience in synthetics controlled bioburden drug product manufacturing with a strong focus on oral solid dose (OSD) processes and innovative technologies (e.g semi-solid) in drug product pharmaceutical manufacturing environments

• Demonstrated expertise in bioavailability enhanced technologies including ASD (amorphous solid dispersions)with deep knowledge of spray dryingand SEDDS or similar innovative enabling formulation approaches

• Proven experience with OSD controlled bioburden manufacturing including batch and continuous manufacturing processes and associated equipment

• Strong understanding of cGMP environments and regulatory expectations for controlled bioburden-drug product manufacturing. Aseptic capability is a plus

• Proven track record of leading multi-functional teams and influencing technical decisions in complex global organizations

• Ability to support earlyphase design detail design Startup processes and Commissioning & Qualification (C&Q) of controlled bioburden (and aseptic) equipment

• Experience with inherently safe containment design for components with low exposure level

• Drive the adoption of digital and dataenabled solutions for DP manufacturing including realtime monitoring advanced process control advanced analytics model and simulation and smart manufacturing use cases where they improve reliability and performance

• Strong customer management and communication skills with the ability to influence across sites functions and external partners

• Strategic attitude combined with handson technical capability

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

• Proficiency in written and spoken English

• Willingness to travel up to 25% domestically and internationally

Preferred:

• Strategic attitude combined with handson technical capability

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

• Additional languages (Dutch Spanish Italian) are an advantage

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