Process Engineer

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.

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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 

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Qualifications:

• Bachelor’s degree in Engineering is required.

• A minimum of 2 years of related experience is required.

• Demonstrated project execution experience.

• Experience in ISO/FDA regulated environments is preferred.

• Experience with qualification, validation, and change control activities is preferred.

• Exposure to Lean, Six Sigma, or structured problem‑solving methodologies is preferred.

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 an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees 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

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