AM Engineering Project

Job Description – AM Engineering Project

Location : Aurangbad(Chh.Sambhaji Nagar)

Industry : Leading Pharmaceutical Company

Role Type : Permanent

Experience : 8 to 10 Years

Function: Engineering Projects & Automation (Global Technical Operation)

Role Purpose :

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

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.

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: 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.