Process Engineer

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Job Description:

Johnson & Johnson Vision Care, Inc. is recruiting for a Process Engineer, located in Jacksonville, FL.

About Vision:

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

The Engineer plans, schedules, and executes moderately complex engineering activities and projects within an assigned manufacturing value stream and/or technical function (e.g., Process, Packaging, Materials/Supplier, Equipment/Validation). The role provides technical leadership to improve safety, quality, delivery, and cost, and supports new product introductions, product/process changes, and compliance commitments in a regulated (GMP/ISO/FDA) environment.

The Engineer leads and/or supports change control, equipment/process/packaging qualification and validation activities (IQ/OQ/PQ as applicable), technical investigations, and continuous improvement initiatives. The role interfaces directly with cross-functional partners (Operations, Quality, Engineering, Supply Chain, and external vendors) to deliver business objectives and ensure robust, compliant solutions.

Responsibilities and accountabilities may vary by site. Applicable procedures and quality systems (e.g., QUMAS/eDMS where applicable) define responsibilities and may supersede elements of this position description.

DUTIES & RESPONSIBILITIES:

Project Delivery & Technical Leadership

·Plans and executes moderately complex engineering and/or change control projects requiring conceptual evaluation, design, and validation.

·Applies standard project management methodologies to plan work, manage scope, and deliver milestones.

·Participates in technical design reviews and translates requirements into manufacturing, product, or equipment specifications.

·Supports capital and expense project justification as applicable.

Qualification, Validation & Change Control

·Plans and executes qualification of new or modified equipment, controls, systems, and/or processes; supports vendor and site acceptance testing as required.

·Leads and/or supports validation activities (IQ/OQ/PQ), protocol execution, and reporting.

·Authors and reviews technical documentation in accordance with GDP and internal standards.

Process / Equipment / Packaging / Materials Improvements

·Identifies and implements equipment, process, packaging, and/or materials enhancements to improve efficiency, yield, reliability, and safety.

·Designs and executes experiments and characterization studies using statistical tools (e.g., DOE, capability, stability, trending).

·Supports packaging or materials qualification activities where applicable.

Troubleshooting, Investigations & CAPA Support

·Performs structured problem solving and root cause analysis for deviations, nonconformances, audit actions, and CAPAs.

·Partners with Operations to address downtime, rejects, and performance issues.

·Provides training and technical support to operations and engineering personnel as appropriate.

Compliance, Risk & Continuous Improvement

·Ensures compliance with applicable GMP, ISO, FDA, and company requirements.

·Participates in risk assessments and continuous improvement initiatives.

·Maintains the highest standards of professionalism, ethics, and compliance.

EXPERIENCE & EDUCATION:

Required:

·Bachelor’s degree in Engineering or related technical discipline.

·2-4 years relevant engineering experience in manufacturing or regulated industry environments.

·Demonstrated project execution experience.

Preferred:

·Experience in ISO/FDA regulated environments.

·Experience with qualification, validation, and change control activities.

·Exposure to Lean, Six Sigma, or structured problem-solving methodologies.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES AND AFFILIATIONS:

·Strong analytical and problem-solving skills.

·Demonstrated technical writing and GDP discipline.

·Effective communication and collaboration skills in matrix environments.

·Strong organizational skills and ability to manage multiple priorities.

·Working knowledge of project management fundamentals.

·Proficiency with common office and data analysis tools.

·Limited domestic and/or international travel may be required based on business needs.

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 & 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 accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

“If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check. www.careers.jnj.com.

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