Process Engineer

Johnson & Johnson MedTech; Puerto De Luna (NM); On-site; USD 90,000 - 120,000; Full time

Job summary

Johnson & Johnson is seeking a skilled Process Engineer in Supply Chain Engineering to plan, schedule, and execute moderately complex engineering activities within a manufacturing value stream. You will provide technical leadership to improve safety, quality, delivery, and cost, and support new product introductions, product/process changes, and compliance commitments in a regulated environment.

Role involves leading/change control, equipment qualification, validation activities, and

Qualifications

• Bachelor's degree in Engineering is required.
• Minimum of 2 years of related experience.
• Experience in ISO/FDA regulated environments preferred.
• Experience with qualification, validation, and change control activities preferred.
• Exposure to Lean, Six Sigma, or structured problem-solving methodologies preferred.

Responsibilities

• Plans, schedules, and executes moderately complex engineering activities and projects within an assigned manufacturing value stream.
• Provides technical leadership to improve safety, quality, delivery, and cost.
• Supports new product introductions, product/process changes, and compliance commitments in GMP/ISO/FDA environments.
• Leads and/or supports change control, equipment/process/packaging qualification and validation activities (IQ/OQ/PQ).
• Performs troubleshooting, investigations and CAPA; partners with Operations to address downtime and performance issues.
• Designs and executes experiments and characterization studies using statistical tools (DOE, capability, stability, trending).
• Identifies and implements equipment, process, packaging, and/or materials enhancements to improve efficiency and reliability.

Skills

Analytical Reasoning

CAPA

Lean

Gemba Kaizen

Issue Escalation

Process Control

Process Engineering

Safety-Oriented

STEM

Technical Research

Education

Bachelor's degree in Engineering

Job description

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

Supply Chain Engineering

Job Sub Function

Process Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Anasco, Puerto Rico, United States of America

Job Description

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.

• 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.

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

Required Skills

Analytical Reasoning, Computerized Equipment Skills, Corrective and Preventive Action (CAPA), Emerging Technologies, Execution Focus, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Process Control, Process Engineering, Process Oriented, Product Improvements, Project Engineering, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy