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.