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Janssen, a member of the Johnson & Johnson Family of Companies is recruiting for a Principal Engineer, Combination Product & Device! This position can be located in Titusville or Raritan, NJ, Spring House or Horsham, PA, Beerse, Belgium and Schaffhausen, Switzerland. Other global Janssen/J&J site locations will also be considered.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies.

Position Summary:

The Principal Engineer, Combination Product & Device PQM ensures that products are being researched, developed, documented, transferred to manufacturing, and sustained, in a manner which aligns with global Combination Product regulations, FDA Design Controls, ISO 13485, ISO 14971 Risk Management, EN 62366 Human Factors, and ICH requirements as well as meets defined user needs and intended uses, while meeting the highest standards of quality and manufacturability.

The Principal Engineer is responsible for providing device and combination product quality engineering support to diverse combination product & devices within Janssen portfolio. This position provides subject matter expertise and has accountability for Design Controls and Risk Management processes, including Product Risk Assessments, Failure Modes and Effects Analysis, Criticality Analysis, Human Factors and other related product development quality requirements to ensure compliance with Device and Combination Products regulatory requirements, industry standards and best practices. This individual may actively participate in and support inspections by internal and external regulatory authorities globally. This position requires using data analytics on product performance data from multiple sources and translating the analysis into Design Inputs for New Product Development or Design Improvements.

Key Responsibilities:

The position will focus on combination products and Device Design Controls, Risk Management and provides end-to-end combination product Quality Engineering and Quality Assurance oversight for Combination Product Development Process and Lifecycle Management.

This position drives a disciplined approach for the rapid, compliant, high quality development, transfer and lifecycle management of combination products across multiple global plant locations while ensuring business and regulatory requirements are achieved. This position is responsible for adhering to environmental and safety policy and procedures and supports department environmental and safety objectives.

• Support all stages of product development and commercialization of Combination Product & Devices for Janssen’s portfolio of products. This includes development and implementation of new quality frameworks for new global regulations and new drug delivery device platforms/technologies.

• Accountable to ensure organization understands and implements a robust and compliant Design Control process & quality system throughout the life cycle of Janssen products.

• Identifies opportunities for improvement in Design Control processes and drives continuous improvement throughout the organization to ensure Design Control processes and systems are efficient and compliant.

• Provide Inspection Support and reviews regulatory submissions and supporting documentation.

• Ensure delivery on commitments and maintain adequate compliance, including projects related to continuous improvement of quality systems.

• Participate in J&J and Pharma sector initiatives related to Combination Product & Device Quality Systems and other related duties as assigned by management.

• Develop and apply advanced knowledge related Data Analysis, Statistics etc.

• Remain current in skills and industry trends. Assures personal training and skill levels remain current by promptly completing assigned training and remaining current in professional and industry knowledge/trends.

• Attend project team meetings as needed and communicate outcomes to supervisor.

• Responsible for ensuring personal and company compliance with all federal, state, local, and company regulations, policies, and procedures for health, safety, and environmental compliance.

• Successfully complete regulatory and job training requirements.

Qualifications

Education:

A minimum of a Bachelor’s or equivalent University degree is required, with a focus in Engineering, Science or another technical field preferred. A Master’s degree or PhD preferred.

Required:

• A minimum of 8 years relevant working experience in medical device, pharmaceutical or biopharmaceutical industry.

• Experience with Quality Systems including ISO 13485, ISO 14971, EN 62366, cGMP, and ICH requirements.

• Knowledge of Combination Product Devices, Biotech and/or Pharma Manufacturing particularly in design controls, Risk management, Design transfer and Human Factors

• Excellent technical writing skills; experienced in SOPs, protocols, reports

• Working knowledge of statistical methods/processes

Preferred:

• Process Excellence, Design Excellence or Six Sigma certified

• FPX Certified

• CQE or CQM

Other:

• Must be proficient in the English language (speak, read & write)

· Prior participation in projects across departments.

• Strong Project Management and Communication Skills

• Strong Decision Making Skills: Makes decisions independently on problems and methods.

• This position may require up to 10% domestic & international travel

The anticipated base pay range for this position is $97,00-193,000 (USD)

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.