Systems Staff Engineer, Large Molecule Drug Product Development | Downingtown, PA

Detailed Information

  • Location: Malvern, PA

  • Company: Johnson And Johnson

count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension.

Visit us: The Staff Engineer in Large Molecule (LM) Drug Product Development (DPD) 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. g. monoclonal antibodies, bi-specifics, gene therapies, cell therapies etc). Key Responsibilities: Lead equipment qualification activities according to industry standards to support drug product medical 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. Education: Minimum of a BS in System or Electrical Engineering with 7 years of experience (including co-op, internships or research experience), or MS with 5 year of work experience is preferred. Experience and Skills: Experience in Gx P automation equipment commissioning, qualifications, and life-cycle management is required.

Experience and knowledge in Gx P Fill/Finish applications is required. Proficiency in sensors and signal conditioning, circuit design/analysis and automation control systems in preferred. Proven proficiency and experience in biologics (m Abs, gene therapies, cell therapies etc) within the medical industry with a high level of technical understanding is preferred. Effective communication skills and demonstrated leadership in providing integration of activities and delivering information across multifunctional groups and sites is required.

This position will be based in Malvern and may require up to 15% international and 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, interaction, interactionual 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. careers.

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