Technical Project Specialist

Biopharma Careers; Jacksonville (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Johnson & Johnson is seeking a Technical Project Specialist in Jacksonville, FL to support R&D and Operations by writing and coordinating protocols for clinical and non-clinical test articles. The role involves multi-disciplinary teamwork to advance vision-related therapies.

You will plan fabrication activities, analyze test data, and contribute to regulatory submissions, while maintaining Design History Records and ensuring compliance with testing requirements.

Qualifications

• Bachelor’s Degree and/or equivalent degree required.
• 2+ years related experience preferred.
• 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.

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.
• 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.

Skills

Analytical Reasoning

Communication

Clinical Data Management

Clinical Operations

Clinical Research

Project Management

Regulatory Knowledge

Study Management

Education

Bachelor’s Degree or equivalent

Job description

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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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

We are searching for the best talent to join our Vision team as a Technical Project Specialist located in Jacksonville, FL. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Purpose

The Technical Project Specialist writes, 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.

You will:

• 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.
• 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.

Qualifications

• Bachelor’s Degree and/or equivalent degree required
• 2+ years related experience preferred
• 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

Other

Ability to travel up to 10%

#LI-AM2

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 ([e-mail]) or contact AskGS to be directed to your accommodation resource.

Preferred Skills

Analytical Reasoning, Business Behavior, Clinical Data Management, Clinical Operations, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials Operations, Communication, Ethical and Participant Safety Considerations, Execution Focus, Innovation, Laboratory Operations, Office Administration, Preclinical Research, Project Management, Research and Development, Study Management