Process Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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 were 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 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 crossfunctional 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:

Bachelors 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 problemsolving 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 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 parents consent for the background check

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