Manufacturing Operations Specialist III

Johnson & Johnson Innovative Medicine•San Jose, CA

2d•$57,500 - $92,575•Onsite

About The Position

The Manufacturing Operations Specialist III is a senior, cross-functional manufacturing role that blends advanced production execution, hands-on product assembly and testing, and manufacturing systems ownership. This position leads day-to-day production readiness, drives work-order lifecycle management in MES/ERP systems, escalates and resolves operational risks, and acts as a subject-matter expert for manufacturing transactions and reporting. The role supports new product introductions and continuous improvement initiatives while mentoring and training junior operations staff. The Specialist III operates in a regulated, clean-room environment and serves as a key liaison among Operations, Planning, Materials, Engineering, and Quality.

Requirements

High school diploma or equivalent experience required.
Minimum 3 - 5 years of manufacturing operations, production control, materials management, supply chain, logistics, or related operational experience in manufacturing environments.
Advanced knowledge of manufacturing operations, production control, material flow concepts, and inventory management.
Demonstrated experience with Manufacturing Execution Systems (MES), SAP/ERP platforms, and inventory management systems
Hands-on assembly experience and ability to perform delicate component handling, integration tasks, and intermediate-level testing in a clean-room environment.
Ability to perform fine-detail assembly and inspection under a microscope for extended periods, including adjusting focus and using microscope-mounted tools while maintaining clean-room technique.
Proficiency in Microsoft Office (especially Excel) and experience building or maintaining operational dashboards and reports (Power BI desirable).
Strong attention to detail, data accuracy, and documentation discipline consistent with GDP.
Demonstrated problem-solving skills, root-cause analysis experience, and ability to drive corrective actions to closure.
Effective written and verbal communication skills and the ability to clearly convey production status, risks, and action plans.
Ability to manage multiple priorities with limited supervision and work effectively in a collaborative, cross-functional environment.
Physical ability to perform the role’s duties (standing, walking, fine motor tasks) and comply with clean-room PPE and behavioral requirements.
Ability to perform other duties and responsibilities as assigned based on business needs, operational requirements, departmental priorities, special projects, cross-functional support, process improvement initiatives, and other tasks that may fall outside the current job responsibilities.

Nice To Haves

Training or education in Supply Chain, Manufacturing, Engineering Technology, or a related technical field.

Responsibilities

Build and assemble catheter and other medical components following Manufacturing Process Instructions (MPI) and established procedures to meet daily build goals, yield, and productivity targets.
Monitor production progress, work order status, inventory availability, Kanban activity, and key operational metrics; proactively identify schedule risks, bottlenecks, and potential impacts to production and support mitigation activities.
Serve as a subject-matter expert for SAP transactions, manufacturing processes, production reporting, and system best practices; troubleshoot manufacturing system issues, navigating ERP systems and transaction discrepancies.
Maintain accurate production and inventory records (Lot History Records, build trackers, production status reports) and support Good Documentation Practices.
Perform material kitting, staging, replenishment, and Kanban activities to support production readiness and uninterrupted operations.
Perform multiple assembly processes for complex designs involving a combination of disciplines and skill sets.
Conduct and support cycle counts, inventory verifications, and reconciliations to maintain system integrity and accurate material records.
Verify accuracy and completeness of manufacturing, inventory, and production data across systems; support corrective actions for discrepancies.
Operate common assembly and measurement tools (microscope, hot box, UV equipment, snap gauge, multimeter, tweezers, pliers) and follow clean-room practices and line clearance procedures.
Collaborate with manufacturing, materials, planning, quality, and R&D teams to resolve product/process issues and support new product introductions.
Maintain organized work areas and system documentation in accordance with safety, quality, and regulatory standards (ISO 13485, 21 CFR 820 / QSR).
Meet training and performance requirements to develop proficiency in manufacturing systems, inventory processes, and production operations.
Participate, lead or support continuous improvement projects focused on operational efficiency, data accuracy, inventory management, and manufacturing execution.
Redline and update MPIs and LHRs as needed; support new product introductions, pilot lines, and process transfers by providing operational feedback and training.

Benefits

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Consolidated retirement plan (pension)
Savings plan (401(k))