AM Engineering Projects

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Job Description – AM Engineering Project

Function: Engineering Projects & Automation (Global Technical Operation)
Grade:(Pay Grade 26)
Reporting to: Engineering Project Manager

Role Purpose

AM Engineering Project – Automation & Machine Building is responsible forend‑to‑end execution of engineering, automation, and custom machine‑building projects, working closely withglobal OEMs, machine builders, and system integrators.

The role combinesstrong project management discipline (PMP preffered),deep automation and controls expertise, andhands‑on machine realization experience to deliversafe, compliant, and high‑performance manufacturing equipment in a regulated environment.

Key Responsibilities

Project Management & Capital Execution

• Leadautomation‑driven engineering and machine‑building projects from user requirements through design, FAT, SAT, commissioning, qualification, and handover.

• Ownproject scope, schedules, budgets, risks, and change management.

• Ensure delivery meetssafety, quality, compliance, cost, and timeline commitments.

• Apply standardizedproject management methodologies for capital projects.

Machine Building & Global Vendor Management (Mandatory)

• Act astechnical project owner for custom‑built machines and automated systems.

• Work directly withglobal 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 approvemechanical, electrical, automation, and software design deliverables.

• Ensure supplier compliance withsafety, 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 developmentServo drives, VFDs, motion controlMachine safety systems

• Lead automation troubleshooting, logic review, performance tuning, and optimization.

• Ensure automation solutions arerobust, standardized, and scalable.

Vision Systems & Advanced Automation

• Lead integration ofCognex (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 approveelectrical schematics, panel layouts, loop diagrams, and instrumentation selection.

• Ensure compliance withelectrical codes, functional safety, and regulatory standards.

• Coordinate electrical installation, testing, and commissioning activities.

Compliance, Validation & Governance

• Ensure projects comply withEHS, machine safety, GMP, Quality Systems, and Data Integrity requirements.

• Lead or supportIQ / OQ / PQ execution for automated equipment.

• Own deviations, root cause investigations, andCAPA implementation related to automation or equipment.

• Maintainaudit‑ready project and validation documentation.

Stakeholder & Team Leadership

• Coordinate withManufacturing, Quality, Validation, IT/OT, Supply Chain, Procurement, and Global Engineering teams.

• Provide technical mentoring and task leadership tojunior 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 inElectrical / Electronics / Instrumentation / Automation Engineering (preferred).

• Strong experience inautomation‑intensive machine‑building or capital projects.

• Mandatory hands‑on exposure to:Global machine vendors / OEMsPLC, HMI, servo drivesCognex or equivalent vision systemsAutomation programming and integration

• Experience inregulated 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: