HireDiversity

Horsham, PA, US

SENIOR PRINCIPAL ENGINEER-8252130111

Description

Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.

Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Janssen Supply Chain is hiring for a Senior Principal Engineer. The first 2-3 years, the position will be based in Cleveland, Ohio. Then the position will be located in Raritan, NJ or Horsham, PA.

The Senior Principal Engineer will provide lead technical support for a range of externally manufactured sterile parenteral pharmaceutical products including bulk formulation, aseptic fill, freeze drying and primary packaging. Knowledge of liposomal based and biologic formulations is advantageous. Knowledge of sterile facility systems including air quality requirements, pressure cascades, and environmental monitoring is required. The main responsibilities include manufacturing process and equipment optimization, trouble-shooting, root-cause investigations, change control evaluation, technology transfer, equipment and utility system qualification, process validation, and cleaning validation. This will require collaboration with internal and external business partners across multiple functional areas including Operations, Engineering, Quality Control / Quality Assurance, Regulatory, Compliance, and external site management. This individual will work independently to execute technical aspects of projects, and interact with and/or lead cross-functional teams to facilitate project completion.

The Senior Principal Engineer will partner with Operations and external partners to ensure continued product supply. This individual will participate in periodic supply meetings, quality meetings, business meetings, and audits as technical lead. The Senior Principal Engineer will handle change evaluation / approval / implementation for raw material changes, process / equipment changes, and product changes. The individual will participate in periodic product quality monitoring efforts to proactively assess and mitigate trends. The Senior Principal Engineer will support external manufacturing sites to define improvement goals and plans, oversee implementation, provide leadership and technical expertise into feasibility assessments and risk management. The individual will lead technical investigations, supporting external site leads and QA during product quality escalations. The Senior Principal Engineer will determine root-cause problems, and define / implement appropriate CAPA's, and ensure mitigation effectiveness. The individual will partner both internally and externally to develop and execute technology transfer plans including scope, detailed tasks, and project schedules. The Senior Principal Engineer will deliver on technical aspects including: equipment procurement, equipment qualification, process development / qualification / validation, and cleaning validation.

Qualifications


This candidate must have a minimum of a BA/BS required. Major in Chemical Engineering, Chemistry, Manufacturing Engineering, Pharmacy or Natural Sciences is preferred. Engineering degree is preferred. Advance degree is preferred.

The incumbent should demonstrate the following: detail and goal oriented, team work, customer-focus, thorough understanding of GMPs and regulatory requirements related to sterile pharmaceutical products is desired. Strong technical knowledge of pharmaceutical product processing (to include QA & compliance requirements) is required. Able to manage multiple projects and adapt to business needs is required. The incumbent must also have a thorough understanding of business requirements, effective communication skills, leadership, interdependent partnering, conflict & change management, influencing & negotiating skills, strong decision-making/ analysis skills, innovation & mastering complexity. Organizational & people development experience is a plus.

Senior professional experience in pharmaceutical manufacturing is required. Quality Assurance, Validation, Process Excellence, Regulatory Compliance, and/or other related areas in a highly regulated industry, such as pharmaceutical, biopharmaceutical, or medical devices is desired. Expertise in document management and change control processes is a plus. Ability to understand and apply statistical techniques to track and analyze process performance and superior problem solving and analytical skills is desired. Demonstrated ability to make sound business judgments; the ability to handle multiple tasks at the same time and efficiently interact and work with multiple processes and departments/sites is desired. Excellent oral and written communications skills are a must.

Must be willing and able to travel 25% based on specific projects and assignments.

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Horsham
Organization: JANSSEN SUPPLY GROUP, LLC (6046)