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Operations Process Engineer (Capital System)

Johnson & Johnson Innovative Medicine

Santa Clara, CAOnsitePosted 35 days ago$75,000 - $120,750/year
Full TimeEntry LevelManufacturing & CMCPharmaceutical
Original posting ↗

Summary

The Operations Process Engineer supports manufacturing execution for the OTTAVA Capital System production line. This hands-on, shop-floor role serves as the first line of technical support for manufacturing test and system integration activities. The engineer will partner with Manufacturing, Test, Quality, and NPI Engineering to maintain production continuity and product quality.

Job description

Responsibilities

  • Ensure uninterrupted manufacturing operations and escalate issues when appropriate.
  • Support manufacturing activities associated with system integration and test.
  • Work directly with Manufacturing Associates and cross-functional engineering partners to identify and resolve technical issues affecting safety, quality, delivery, or production continuity.
  • Investigate manufacturing test failures using structured troubleshooting and problem-solving methods.
  • Troubleshoot test hardware, software, and system interfaces.
  • Document findings, define containment actions, and partner with Test, NPI Engineering, and Quality on permanent corrective actions.
  • Capture technical knowledge and recurring failure modes to improve troubleshooting consistency and reduce production downtime.
  • Support change controls, CAPAs, NCRs, and related quality system activities.
  • Participate in nonconformance investigations, root cause analysis, impact assessments, and implementation of corrective and preventive actions.
  • Ensure assigned manufacturing and documentation activities are performed in accordance with approved procedures and applicable quality requirements.

Required Skills & Experience

  • Bachelor's degree in Engineering or a related technical discipline.
  • 0-4 years of relevant engineering experience.
  • Internship, co-op, academic project, research, or laboratory experience may be considered.
  • Hands-on experience with engineering testing, system integration, scripting, or technical troubleshooting through academic or professional work.
  • Ability to interpret test results and systematically troubleshoot hardware, software, and system-level failures.
  • Basic scripting experience, preferably with Python, and the ability to read and debug scripts.
  • Strong analytical, problem-solving, technical writing, and communication skills.
  • Ability to work effectively with Manufacturing, Test Engineering, Quality, NPI Engineering, and R&D partners.
  • Ability to work 100% onsite.

Preferred Skills & Experience

  • Experience with Python, LabVIEW, MATLAB, automated test systems, data acquisition tools, SQL, or manufacturing data analysis.
  • Experience troubleshooting electromechanical systems, robotic systems, complex capital equipment, or integrated hardware/software products.
  • Exposure to a regulated manufacturing environment such as medical devices, pharmaceuticals, biotechnology, aerospace, or automotive.
  • Familiarity with change controls, CAPAs, NCRs, root cause analysis, and corrective action processes.
  • A hands-on, ownership-oriented approach and the ability to respond with urgency to production issues while maintaining quality and compliance.

Requirements

  • Bachelor's degree in Engineering or a related technical discipline
  • 0-4 years of relevant engineering experience
  • Hands-on experience with engineering testing, system integration, scripting, or technical troubleshooting
  • Ability to interpret test results and systematically troubleshoot hardware, software, and system-level failures
  • Basic scripting experience, preferably with Python, and ability to read and debug scripts
  • Strong analytical, problem-solving, technical writing, and communication skills
  • Ability to work effectively with cross-functional partners
  • Ability to work 100% onsite

Benefits

  • Pension plan
  • 401(k) savings plan
  • Vacation
  • Sick time
  • Holiday pay
  • Floating holidays
  • Parental leave
  • Bereavement leave
  • Caregiver leave
  • Volunteer leave
  • Military spouse time-off

Company overview

Johnson & Johnson Innovative Medicine is the pharmaceutical division of Johnson & Johnson, leading the way in medical innovation with a relentless focus on bringing transformational treatments to patients worldwide. The company applies rigorous science and compassion to address the most complex diseases of our time, developing groundbreaking medicines across key therapeutic areas including oncology, immunology, neuroscience, and cardiopulmonary medicine. With deep expertise and global reach, Johnson & Johnson Innovative Medicine reimagines how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families. The organization pioneers the path from laboratory research to clinical application, championing patients every step of the way while maintaining an unwavering commitment to scientific excellence and patient-centered innovation.

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