Technical Project Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function:R&D Operations Job Sub Function:Clinical/Medical Operations Job Category:Professional All Job Posting Locations:Jacksonville, Florida, United States of America Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech #Li-Hybrid An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent forTechnical Project Specialistto be inJacksonville, FL. TheTechnical Project Specialistwrites, oversees and facilitates protocols to produce clinical and non-clinical test articles in support of R&D and Operations initiatives. Works as an active participant in multi-disciplinary teams involved in test article research and development. Provides technical assistance to project teams. Provides clarification and/or resolution to project challenges. Communicates and facilitates required testing for release of test articles to the clinic. Writes and coordinates technical protocols and/or reports in support of stability studies and regulatory submissions. Organizes and assembles Design History Records for protocols run in operations. Gathers and analyzes test article data in support of research projects. Adheres to safety and environmental policies and procedures and supports department safety and environmental objectives. Engages in Credo-based decision-making. Duties and Responsibilities: • Plan, write, and execute test article fabrication of clinical and non-clinical protocols for research projects • Gather and analyze insert data, plastic data, and/or lens parameter data for the project teams Create lens parameter, property, biocompatibility, and analytical testing submissions • Create lens parameter, property, biocompatibility, and analytical testing submissions • Update and obtain approval of Use and Misuse-Risk Assessment Protocol Tracking to reflect release requirements • Organize and assemble Design History Records for protocols run in operations • Write and/or revise procedures as needed • Interface with the Pilot Line, QA, Operations, and management to facilitate test article builds, testing, and release • Work in conjunction with project managers and team members to understand expected outcomes and define requirements • Provide technical input and guidance for the evaluation of test articles manufactured from new or alternate platforms Qualifications: • Bachelor’s Degree preferably in the Science or Engineering discipline • At least a year of related work experience (FDA regulated industry or contact lens manufacturing) • Proficiency in MS Office software, ability to create, manage, and maintain documentation • Excellent written and verbal communication • Interpersonal and organizational skills • Attention to detail Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.