Staff Process Engineer

Posted 4 Days Ago
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Jacksonville, FL, USA
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Provides technical leadership for complex process engineering projects in a regulated medical device manufacturing environment. Leads change control, qualification and validation, experimental studies, troubleshooting, continuous improvement, risk management, CAPA, and technical documentation. The role improves manufacturing safety, quality, delivery, cost, and reliability while mentoring engineers and collaborating with cross-functional teams, suppliers, contractors, and global stakeholders.
Summary Generated by Built In

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 6–8+ years for Staff Engineer scope; some specialist tracks may require 7+ years (Packaging) or 9–10+ years (Materials/Supplier / Technical Operations / Supply Chain-focused roles).

REQUIRED KNOWLEDGE, SKILLS, ABILITIES:

  • Deep technical expertise and ability to independently develop novel approaches to solve complex problems; recognized as a go-to technical resource.
  • Advanced analytical/statistical capability (e.g., DOE, capability/stability, hypothesis testing, data trending) and ability to translate data into decisions.
  • Strong project/program management skills (scope, schedule, risk, budget) and ability to deliver in a matrix environment.
  • Strong technical writing, presentation, and documentation control discipline; ensures accurate generation, release, and maintenance of compliant documentation.
  • Influencing and collaboration skills across functions, sites, cultures, and time zones; ability to lead through ambiguity.
  • ·Knowledge of regulated manufacturing requirements (GMP/ISO/FDA) and risk management practices.
  • For Packaging roles (as applicable): strong working knowledge of relevant packaging standards, regulations, and test methods; distribution/transportation testing and packaging process validation.
  • For Supplier/Materials/Tech Ops roles (as applicable): strong supplier engagement skills; ability to assess supplier capability/capacity and lead investigations and continuity-of-supply actions.
  • Proficiency in common business tools and statistical software (e.g., Excel, JMP/Minitab or equivalents) as appropriate to the role.
  • Language requirements: English required; additional language requirements site-dependent. 

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, please contact us via https://www.jnj.com/contact-us/careers or 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:



Preferred Skills:

Skills Required

  • Bachelor's degree in Engineering or a related technical discipline, or equivalent technical degree
  • Experience leading complex technical projects in manufacturing, operations, or regulated industry environments
  • Strong technical writing and documentation discipline, including GDP-compliant documentation
  • Ability to influence and collaborate with cross-functional stakeholders
  • English language proficiency
  • Advanced degree in Engineering or Science
  • Professional engineering certification, PMP/PMI credential, or Lean/Six Sigma/FPx certification
  • Deep domain expertise in process engineering, packaging, materials science, supplier engineering, validation systems, or data analytics
  • Experience working directly with vendors or suppliers and leading cross-site or global initiatives
  • Six to eight or more years of experience for Staff Engineer scope; specialist tracks may require seven or more or nine to ten or more years
  • Advanced analytical and statistical capability, including DOE, capability and stability analysis, hypothesis testing, and data trending
  • Strong project and program management skills covering scope, schedule, risk, and budget
  • Knowledge of regulated manufacturing requirements, including GMP, ISO, FDA, and risk management practices
  • Proficiency with Excel and statistical software such as JMP, Minitab, or equivalents

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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