The role combines strong project management discipline (PMP preffered), deep automation and controls expertise, and hands‑on machine realization experience to deliver safe, compliant, and high‑performance manufacturing equipment in a regulated environment.
Key Responsibilities
Project Management & Capital Execution
Lead automation‑driven engineering and machine‑building projects from user requirements through design, FAT, SAT, commissioning, qualification, and handover.
Own project scope, schedules, budgets, risks, and change management.
Ensure delivery meets safety, quality, compliance, cost, and timeline commitments.
Apply standardized project management methodologies for capital projects.
Machine Building & Global Vendor Management (Mandatory)
Act as technical project owner for custom‑built machines and automated systems.
Work directly with global machine suppliers, OEMs, and system integrators during: Concept and detailed design Machine build and integration FAT at vendor sites (global) Installation, SAT, ramp‑up, and handover
Review and approve mechanical, electrical, automation, and software design deliverables.
Ensure supplier compliance with safety, quality, validation, and J&J engineering standards.
Automation, Controls & Programming
Provide strong technical leadership and/or hands‑on expertise in: PLC systems (ladder logic / structured text) HMI / SCADA development Servo drives, VFDs, motion control Machine safety systems
Lead automation troubleshooting, logic review, performance tuning, and optimization.
Ensure automation solutions are robust, standardized, and scalable.
Vision Systems & Advanced Automation
Lead integration of Cognex (or equivalent) vision systems for inspection, verification, and traceability.
Define vision system requirements, acceptance criteria, and commissioning strategy.
Support long‑term system reliability and performance.
Electrical & Instrumentation Engineering
Review and approve electrical schematics, panel layouts, loop diagrams, and instrumentation selection.
Ensure compliance with electrical codes, functional safety, and regulatory standards.
Coordinate electrical installation, testing, and commissioning activities.
Compliance, Validation & Governance
Ensure projects comply with EHS, machine safety, GMP, Quality Systems, and Data Integrity requirements.
Lead or support IQ / OQ / PQ execution for automated equipment.
Own deviations, root cause investigations, and CAPA implementation related to automation or equipment.
Maintain audit‑ready project and validation documentation.
Stakeholder & Team Leadership
Coordinate with Manufacturing, Quality, Validation, IT/OT, Supply Chain, Procurement, and Global Engineering teams.
Provide technical mentoring and task leadership to junior engineers or automation resources.
Communicate project progress, risks, and mitigation plans to engineering leadership.
Compliance Knowledge Requirements
Demonstrated working knowledge and practical application of
Machine Safety & Functional Safety: ISO 12100, ISO 13849 (Cat / PL), IEC 62061, ISO 13857, ISO 14119, ISO 14120
Electrical Safety: IEC 60204‑1
Automation Standards: IEC 61131‑3, industrial networks, safety PLC concepts
Medical Device & Quality: ISO 13485, FDA 21 CFR Part 820 principles
GMP & Data Integrity: EU GMP Annex 15, ICH Q7/Q9/Q10 concepts, ALCOA+, 21 CFR Part 11 awareness
Equipment Qualification: IQ, OQ, PQ; risk‑based validation; controlled FAT/SAT with vendors
Internal Standards: J&J Machine Safety / Zero‑Access (ZAMG) and risk assessment practices
Qualification & Experience
Degree in Electrical / Electronics / Instrumentation / Automation Engineering (preferred).
Strong experience in automation‑intensive machine‑building or capital projects.
Mandatory hands‑on exposure to: Global machine vendors / OEMs PLC, HMI, servo drives Cognex or equivalent vision systems Automation programming and integration
Experience in regulated manufacturing (MedTech / Pharma) preferred.
Ability to find root cause through QMS driven approach & awareness of CAPA Process
Role Positioning
This role is hands‑on technical execution leadership role.
Expected to operate independently with minimal supervision.
Required Skills
Preferred Skills
Artificial Intelligence (AI), Controls Compliance, Critical Thinking, Industrial Robotics, Industry Analysis, Innovation, Lean Supply Chain Management, Machine Learning (ML), Management Systems Implementation, Organizing, Problem Solving, Project Management, Prototyping, Robotic Automation, Science, Technology, Engineering, and Math (STEM) Application, Smart Systems, Technologically Savvy
