Principal Engineer, Combination Products & Emerging Technologies PQM-00000SZD
Description
Janssen Supply Group, LLC is recruiting for a Principal Engineer, Combination Products & Emerging Technologies PQM. The position can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Malvern, PA; Horsham, PA; Gurabo, PR; Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; or Schaffhausen, Switzerland or any other Janssen/JnJ site.
Janssen Pharmaceuticals Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
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.
The Principal Engineer, Combination Products & Emerging Technologies PQM position participates as a Quality Assurance & Quality Engineering team member providing guidance, training and consultation on Combination Product/Device and Emerging Technology on new product development and commercialization projects. The Principal Engineer works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Strong project management and communication skills required. The position will focus on combination products and emerging technologies Design Controls and Risk Management leadership, such as combination products, stem cell technology, mobile medical applications, etc. The role participates as a project team member and assumes ownership for end-to-end combination product Quality Assurance oversight for CMC development and the Supply Chain New Product Launch teams for the molecules/devices/products assigned.
The Principal Engineer, Combination Product & Emerging Technologies PQM ensures that products are being researched, developed, documented, transferred to Manufacturing, and sustained, in a manner which complies with 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 support at Janssen, and supports the implementation of quality frameworks for emerging technologies. This position provides subject matter expertise and has accountability for Design Controls and Risk Management processes, including Criticality Analysis, practices and systems and other related product development QA 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 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. It provides quality oversight for Janssen Device, Combination Product & Emerging Technology Development, while ensuring design control and risk management procedures are harmonized, integrated and understood by key business partners across multiple departments and plant locations. This individual is responsible for adhering to environmental and safety policy and procedures and supports department environmental and safety objectives.
Qualifications
A Bachelor’s Degree with 8+ years related experience in medical device, pharmaceutical or biopharmaceutical industry OR a Master’s degree with 7+ years’ experience in the same industry OR a PhD with 5+ years related experience in the same industry is required. A degree in Chemistry, Biology, Engineering or other scientific discipline is preferred. Experience with Quality Systems, ISO 13485, ISO 14971, EN 62366, cGMP and/or ICH Requirements is required. Knowledge of Devices, Biotech and/or Pharma Manufacturing required, particularly in technology transfer/design transfer, Design Controls and Risk Management is required. Black Belt or Master Black Belt is preferred. Working knowledge of Statistical Methods/Processes is required. Excellent technical writing skills; experienced in SOPs, protocols and reports is required. FPX Certified or trained is preferred. CQE or CQM preferred. Experience in a virtual and/or global team is preferred.
Ability to progress into a people leadership and management role is required. Prior leadership of and participation in projects across departments is required. Qualified candidates must have strong Project Management, Communication Skills, Strong Decision Making Skills. Makes decisions independently on problems and methods. Conflict Management skills are required.
This position will require up to 25% travel, both domestic and international.
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Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America, Europe/Middle East/Africa
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Travel:Yes, 25 % of the Time
Job Function: Engineering (Generalist)
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