The Staff 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 Staff Engineer is responsible for providing device and combination product quality support and implements new quality frameworks for novel drug delivery technologies. 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, and other related product development quality systems to ensure compliance with Device and Combination Products regulatory requirements, industry standards, and Design Transfer requirements for the introduction of new products into manufacturing. 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.
This individual may actively participate in and support inspections by internal and external regulatory authorities globally.
This position requires participation on product teams to drive a disciplined approach for the rapid, compliant, high quality development and transfer of new products across multiple 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 & Device for Janssen’s portfolio of products. This includes development and implementation of new quality frameworks for new and emerging drug delivery device platforms/technologies.
• Collaborate with other functions to drive continuous improvement throughout department to ensure most efficient use of resources to deliver value-added support; Establish and maintain best practices, ideas and methodologies.
• Provide Inspection Support and reviews regulatory submissions and supporting documentation.
• Responsible for ensuring personal and company compliance with all federal, state, local, and company regulations, policies, and procedures for health, safety, and environmental compliance.
• 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 to Design, Data Analysis, Advanced 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.
• Maintain relevant and necessary GMP knowledge.
• Assist in the development and training of staff members.
• Attend project team meetings as needed and communicate outcomes to supervisor.
• Participate on technical or other internal teams, as required.
• Carry out duties in compliance with all local, state, and federal and international regulations and guidelines including EMEA, FDA, EPA, OSHA, and global health authorities as applicable. Comply with all company and site policies and procedures.
• Successfully complete regulatory and job training requirements.
•Bachelor’s Degree in Engineering, Science or other scientific or technical field required. Advanced degree preferred.
• A minimum of 5 years related 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 technology transfer/design transfer, design controls and risk management
• Strong Decision-Making Skills: Makes decisions independently on problems and methods
• Excellent technical writing skills; experienced in SOPs, protocols, reports
• Working knowledge of statistical methods/processes
• Proactively identify issues and take steps to resolve within team
• Proficient in English
Preferred Experience and skills
• Six Sigma, Black Belt or Master Black Belt
• FPX Certified
• CQE or CQM
• Prior leadership of and participation in projects across departments: Strong project management and communication skills
• Conflict Management and Facilitation skills
• Ability to speak, present and/or respond before groups of customers, employees, Regulatory agencies, clients, and to address common inquiries
• Ability to write routine business reports and correspondence or procedure manuals using original, prescribed, or innovative techniques or styles
Johnson & Johnson family employers value diversity and inclusion. We are committed to building diverse teams that reflect the patients and partners we support. We strive to create an inclusive work environment where our people feel at home and have the space to reach their full potential.