AM Engineering Projects

Biopharma Asia; Chhatrapati Sambhajinagar District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Biopharma Asia is seeking an AM Engineering Project professional within Supply Chain Engineering to drive automation and machine-building initiatives. This role operates under the Global Technical Operation and collaborates with OEMs, machine builders, and system integrators to deliver safe, compliant manufacturing equipment in regulated environments.

The role blends strong project management discipline with deep automation and controls expertise, plus hands-on machine realization experience to

Qualifications

• Strong project management experience and PMP is preferred.
• Extensive automation, controls and machine-building expertise.
• Hands-on experience with global vendors and capital projects.

Responsibilities

• Lead automation-driven engineering and machine-building projects from requirements through design, FAT, SAT, commissioning, qualification, and handover.
• Own project scope, schedules, budgets, risks, and changes.
• Ensure safety, quality, compliance and timeline commitments.
• Coordinate with global vendors and system integrators during concept, design, build, installation and handover.

Skills

Project management

Automation expertise

Machine building experience

Education

Electrical/Electronics/Instrumentation/Automation Engineering

Tools

PLC systems

HMI/SCADA

Servo drives

Job description

Job Function:

Supply Chain Engineering

Job Sub Function:

Automation Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Aurangabad, Maharashtra, India

Job Description:

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 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, 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