Staff Process Engineer

Job description

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. Job Function: Supply Chain Engineering Job Sub Function: Process Engineering Job Category: Scientific/Technology All Job Posting Locations: Jacksonville, Florida, United States of America Job Description: Johnson & Johnson is recruiting for a Staff Process Engineer, to join Vision Care team in Jacksonville, FL. About Vision:Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Purpose: The Staff Engineer provides deep technical expertise and strategic technical leadership within an assigned manufacturing value stream and/or engineering function (e.g., Process, Packaging, Materials/Supplier, Equipment/Validation, Technical Operations). The role leads complex, high-impact projects and programs that improve safety, quality, delivery, cost, and long-term competitiveness in a regulated (GMP/ISO/FDA) environment. The Staff Engineer is accountable for end-to-end execution of initiatives including change control, qualification/validation (IQ/OQ/PQ as applicable), characterization and experimental studies, technical investigations, and continuous improvement. The role influences decisions across the organization, mentors engineers and technical team members, and collaborates with cross-functional stakeholders and external partners to deliver robust, compliant, sustainable 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. DUTIES & RESPONSIBILITIES: 1. Technical Leadership, Strategy & Governance Acts as a senior technical contributor and key technical voice within the function and cross-functionally; drives technical direction on complex problems. Partners with cross-functional governance / prioritization forums to scope, plan, and deliver high-value programs aligned to business objectives. Identifies, proposes, and leads breakthrough/best-practice methodologies and technology improvements to raise capability and performance. 2. Project / Program Leadership & Delivery Leads complex engineering projects/programs requiring conceptual evaluation, design, and validation; establishes milestones, resourcing, schedules, risks, and budgets. Applies standard project management methods and continuous improvement tools (e.g., Lean/Six Sigma) to deliver results and sustain gains. Performs concept analysis for future capital/expense projects; supports business case development and justification as applicable. May supervise and coordinate outside designers, consultants, contractors, and/or other supplemental resources required for delivery. 3. Change Control, Qualification & Validation Leads complex change control activities (global and local, as applicable) ensuring compliance with internal procedures and external regulations/standards. Plans and executes qualification and validation of new/modified equipment, processes, systems, packaging operations, and/or materials (IQ/OQ/PQ as applicable). Authors/reviews/approves high-quality technical documentation (protocols, reports, specifications, risk assessments, presentations) in accordance with GDP and internal standards. 4. Engineering Excellence (Process / Equipment / Packaging / Materials / Supplier) – as applicable Identifies and implements equipment/process/packaging/material enhancements that improve efficiency, yield, reliability, robustness, and safety. Designs, executes, and analyzes complex experimental studies (e.g., DOE, capability/stability, hypothesis testing, trend analysis) to optimize performance and support decision-making. Leads technical troubleshooting and optimization across manufacturing platforms; supports NPI/technical transfer and platform development where applicable. For Packaging-focused assignments: leads packaging system/component qualification and packaging equipment/process validations; leads shipping/distribution/route verification testing; supports labeling and packaging implementation content; drives sustainability and cost improvement initiatives; ensures compliance with applicable packaging standards and regulations. For Materials/Supplier or Technical Operations assignments: leads supplier/material capability evaluations, capacity/risk assessments, and continuity-of-supply actions; leads complex quality/failure investigations with suppliers; engages cross-site partners where common supply streams exist. 5. Investigations, Risk Management & CAPA Leads and/or coaches structured problem-solving and root cause analysis for complex quality/technical/manufacturing issues (e.g., deviations, nonconformances, audit actions, CAPAs). Ensures risk-based thinking is applied to solutions; drives robust corrective/preventive actions and verifies effectiveness. 6. Coaching, Mentoring & Capability Building Mentors and provides technical guidance to engineers and technical team members; builds functional capability, standard work, and technical excellence. Provides training/support to operations/engineering teams on relevant methodologies, tools, and safe operation/troubleshooting of processes and equipment. 7. Compliance, Safety, Ethics & Professional Standards Ensures adherence to applicable regulations, standards, and company policies; maintains the highest standards of professionalism, ethics, and compliance. Supports EHS and sustainability objectives relevant to assigned scope and initiatives. EXPERIENCE & EDUCATION: Bachelor’s degree in Engineering or related technical discipline (or equivalent technical degree appropriate to the function). Demonstrated experience leading complex technical projects in manufacturing/operations and/or regulated industry environments. Strong technical writing and documentation discipline (GDP), and demonstrated ability to influence cross-functional stakeholders. Preferred: Advanced degree (Master’s or PhD) in Engineering/Science. Professional engineering certification and/or recognized project management credentials (e.g., PMP/PMI) and/or continuous improvement certification (Lean/Six Sigma/FPx or equivalent). Deep domain expertise relevant to the assignment (e.g., advanced process engineering, packaging standards and test methods, materials science/supplier engineering, validation systems, data analytics). Experience working directly with vendors/suppliers and leading cross-site/global initiatives. Typical Experience Range (site/discipline dependent): ·Generally