Product/Process Engineer

Johnson & Johnson•Jacksonville, FL

3d•Onsite

About The Position

Johnson & Johnson is recruiting a Product/Process Engineer to join our Vision team in Jacksonville, FL. 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.

Requirements

Bachelor’s degree in Engineering or related technical discipline.
Typically 2–4 years relevant engineering experience in manufacturing or regulated industry environments.
Demonstrated project execution experience.
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.

Nice To Haves

Experience in ISO/FDA regulated environments.
Experience with qualification, validation, and change control activities.
Exposure to Lean, Six Sigma, or structured problem‑solving methodologies.
Strong analytical and problem-solving skills.

Responsibilities

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.
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.
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.
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.
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.