Senior Process Engineering

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 Med Tech, 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.

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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.

Supply Chain Engineering

Process Engineering

Scientific/Technology

Anasco, Puerto Rico, United States of America

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

The Senior Engineer provides technical leadership within an assigned manufacturing value stream and/or engineering function (e.g., Process, Packaging, Materials/Supplier, Equipment/Validation). The role leads complex engineering projects and initiatives supporting safety, quality, delivery, cost, and innovation objectives in a regulated (GMP/ISO/FDA) environment. The Senior Engineer is accountable for end-to-end execution of change control and validation/qualification activities (IQ/OQ/PQ as applicable), technical investigations, continuous improvement, and cross-functional delivery.

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.

• Project Leadership & Delivery
  - Leads and executes complex engineering and/or change control projects requiring conceptual evaluation, design, and validation. Applies project management methodologies to define scope, schedule, resources, risks, and deliverables; drives timely execution and closure. Performs concept analysis and supports development of capital/expense project justifications for future project development. Participates in and/or leads technical design reviews; translates requirements into robust manufacturing/product/equipment specifications.
• Qualification, Validation & Change Control
  - Plans and executes complex qualification of new or modified equipment, controls, systems, processes, and/or packaging operations; supports vendor and site acceptance testing (FAT/SAT) as required. Leads validation strategy and execution (IQ/OQ/PQ), including protocol authoring, execution oversight, deviation management, and report approval. Ensures high-quality technical documentation (protocols, reports, risk assessments, work instructions, specifications) in compliance with GDP and internal/regulatory standards.
• Process / Packaging / Materials & Supplier Engineering (as applicable) - Identifies and implements process, equipment, packaging, and/or materials enhancements that improve efficiency, yield, reliability, robustness, and safety. Designs and executes characterization studies and experiments using statistical/analytical tools (e.g., DOE, capability, stability, trending) to set new performance standards and drive breakthrough improvements. For packaging-focused assignments: leads packaging system design/development/validation and maintenance activities;
  
  qualifies packaging components/systems; establishes packaging specifications; leads packaging process/equipment validations; and supports labeling/packaging improvements aligned with applicable standards and regulatory requirements. For materials/supplier-focused assignments: serves as functional SME; leads material characterization, worst-case/challenge testing and qualification activities for new/revised…