STAFF ENGINEER, LARGE MOLECULE DRUG PRODUCT DEVELOPMENT & DELIVERY

Janssen Research & Development, L.
.
., a division of Johnson & Johnson's Family of Companies is recruiting for a Staff Engineer, Large Molecule Drug Product Development & Delivery, located in Malvern, PA.
About Johnson & Johnson 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 https://www.
nj.
om/.
The Staff Engineer in Large Molecule (LM) Drug Product Development & Delivery (DPD&D) will work independently and in conjunction with the development teams to support program/project needs.
The candidate will also independently lead, design, and perform development and engineering activities in support of process and fill-finish activities for large molecules (e.
.
monoclonal antibodies, bi-specifics, gene therapies, cell therapies, etc).
Key Responsibilities.
Lead equipment qualification activities according to industry standards to support drug product pharmaceutical manufacturing and R&D activities.
Lead, facilitate, and participate in technical discussions to successfully resolve problems with equipment suppliers, methods, project issues, and deviations.
Design, develop and deploy automation within manufacturing unit operations to ensure competitiveness and organizational excellence.
Progress the technical understanding of process impact on drug product, ensuring consistent scientific excellence and scientific quality standards are met.
Lead, support, and contribute to internal Fill/Finish activities in support of Lead Stability Development batch manufacturing.
Responsible for ongoing production and continuous improvement initiatives.
Opportunity to develop process engineering skills including the use of multiphysics software for process modeling and the statistical analysis of data.
Qualifications Education.
Minimum of a BS in System or Electrical Engineering with 7 years of experience (including co-op, internships or industry experience) is required.
MS with 5 years of work experience is preferred.
Experience and Skills.
Experience in GxP automation equipment commissioning, qualifications, and life-cycle management is required.
Experience and knowledge in GxP Fill/Finish applications is preferred.
Proficiency in sensors and signal conditioning, circuit design/analysis and automation control systems is preferred.
Proven proficiency and experience in biologics (mAbs, gene therapies, cell therapies, etc) within the pharmaceutical industry with a high level of technical understanding is preferred.
Effective communication skills by delivering information across multifunctional groups/sites and demonstrated leadership in providing integration of activities is required.
This position will be based in Malvern and may require up to 15% international/ domestic travel.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.