Staff Process Engineer

Johnson & Johnson Innovative Medicine•Jacksonville, FL

2d•Onsite

About The Position

Johnson & Johnson is recruiting a Staff Process Engineer for its Vision Care team in Jacksonville, Florida. The role provides deep technical expertise and strategic technical leadership within a manufacturing value stream and/or engineering function. It leads complex, high-impact projects and programs intended to 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 and validation (IQ/OQ/PQ as applicable), characterization and experimental studies, technical investigations, and continuous improvement. The position influences organizational decisions, mentors engineers and technical team members, and collaborates with cross-functional stakeholders and external partners to deliver robust, compliant, sustainable solutions. Responsibilities may vary by site; applicable procedures and quality systems define responsibilities and may supersede elements of the position description.

Requirements

Bachelor’s degree in Engineering or a related technical discipline, or an 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, including GDP practices.
Demonstrated ability to influence cross-functional stakeholders.
Deep technical expertise and ability to independently develop novel approaches to complex problems.
Advanced analytical/statistical capability, such as DOE, capability/stability analysis, hypothesis testing, and data trending, and ability to translate data into decisions.
Strong project/program management skills covering scope, schedule, risk, and budget, with ability to deliver in a matrix environment.
Strong technical writing, presentation, and documentation control skills, including accurate generation, release, and maintenance of compliant documentation.
Influencing and collaboration skills across functions, sites, cultures, and time zones, and ability to lead through ambiguity.
Knowledge of regulated manufacturing requirements (GMP/ISO/FDA) and risk management practices.
Proficiency in common business tools and statistical software, such as Excel and JMP/Minitab or equivalents, as appropriate to the role.
English language proficiency.
Typical experience range is generally 6–8+ years for Staff Engineer scope; specialist tracks may require 7+ years for Packaging or 9–10+ years for Materials/Supplier, Technical Operations, or Supply Chain-focused roles.

Nice To Haves

Advanced degree (Master’s or PhD) in Engineering or Science.
Professional engineering certification, recognized project management credentials such as PMP/PMI, and/or continuous improvement certification such as Lean/Six Sigma/FPx or equivalent.
Deep domain expertise relevant to the assignment, such as advanced process engineering, packaging standards and test methods, materials science/supplier engineering, validation systems, or data analytics.
Experience working directly with vendors/suppliers and leading cross-site or global initiatives.
For packaging roles, strong working knowledge of relevant packaging standards, regulations, test methods, distribution/transportation testing, and packaging process validation.
For Supplier/Materials/Technical Operations roles, strong supplier engagement skills and ability to assess supplier capability/capacity and lead investigations and continuity-of-supply actions.
Additional languages, depending on site requirements.

Responsibilities

Act as a senior technical contributor and key technical voice within the function and cross-functionally, driving technical direction on complex problems.
Partner with governance and prioritization forums to scope, plan, and deliver programs aligned with business objectives.
Identify, propose, and lead breakthrough or best-practice methodologies and technology improvements.
Lead complex engineering projects and programs, establishing milestones, resources, schedules, risks, and budgets.
Apply project management methods and continuous improvement tools such as Lean/Six Sigma to deliver results and sustain gains.
Perform concept analysis for future capital and expense projects and support business case development and justification as applicable.
Coordinate outside designers, consultants, contractors, or supplemental resources when needed.
Lead complex change control activities while ensuring compliance with internal procedures and external regulations and standards.
Plan and execute qualification and validation of new or modified equipment, processes, systems, packaging operations, and/or materials, as applicable.
Author, review, or approve technical documentation, including protocols, reports, specifications, risk assessments, and presentations, in accordance with GDP and internal standards.
Identify and implement equipment, process, packaging, or material improvements that enhance efficiency, yield, reliability, robustness, and safety.
Design, execute, and analyze complex experimental studies such as DOE, capability/stability studies, hypothesis testing, and trend analysis.
Lead technical troubleshooting and optimization across manufacturing platforms; support NPI, technical transfer, and platform development where applicable.
For packaging-focused assignments, lead packaging system/component qualification, packaging equipment/process validation, shipping/distribution/route verification testing, packaging implementation content, sustainability and cost improvement initiatives, and compliance with applicable standards and regulations.
For materials/supplier or technical operations assignments, lead supplier/material capability evaluations, capacity and risk assessments, continuity-of-supply actions, and complex supplier quality/failure investigations; engage cross-site partners as needed.
Lead or coach structured problem-solving and root-cause analysis for complex quality, technical, or manufacturing issues, including deviations, nonconformances, audit actions, and CAPAs.
Apply risk-based thinking, drive corrective and preventive actions, and verify their effectiveness.
Mentor and provide technical guidance to engineers and technical team members; build functional capability, standard work, and technical excellence.
Provide training and support to operations and engineering teams on relevant methodologies, tools, and safe operation or troubleshooting of processes and equipment.
Ensure adherence to applicable regulations, standards, and company policies, and support relevant EHS and sustainability objectives.