Validation Engineer

Nextup Hr Consulting; Hyderabad, Chennai District, Bengaluru; On-site; INR 600,000 - 800,000; Full time

Job summary

An Industrial Automation Machines Manufacturing in Bengaluru seeks a Junior/Validation Engineer to ensure qualification projects meet customer requirements, conduct kick-off meetings, and document the Qualification Master Plan (QMP). The role focuses on GMP-regulated environments and the creation of test protocols such as Pre-FAT, FAT, SAT, IQ, and OQ in collaboration with the customer and project team.

You will perform PFMEA, maintain document status lists, stay updated with regulatory changes,

Qualifications

• Diploma or degree in Mechatronics or Electrical Engineering.
• Experience with validation/qualification in pharma or pharmaceutical machine manufacturing is preferred.
• Good command of English, both written and spoken.

Responsibilities

• Ensure the qualification project aligns with customer requirements if a qualification package is ordered.
• Clarify the customer\'s qualification requirements during the qualification kick-off meeting.
• Document the agreements from the qualification kick-off meeting in the Qualification Master Plan (QMP).
• Conduct PFMEA for the machine and document it.
• Create test protocols, including Pre-FAT, FAT, SAT, IQ, and OQ.
• Perform qualification tests (Pre-FAT, FAT, SAT, IQ, OQ) and record deviations and follow up.
• Contact person for the customer and project team in qualification matters.
• Maintain an overview of all DQ and test documents, keep a document status list, stay updated with Pharma Regulatory changes, or scope of the order change and incorporate technical changes into FMEA.

Skills

PFMEA

FAT/IQ/OQ

GMP knowledge

Communication

Travel readiness

Documentation

HMI/PLC basics

Education

Diploma in Mechatronics or Electrical Engineering

Tools

Wiring diagrams

Pneumatic diagrams

FMEA software

Job description

JOB DESCRIPTION:

POSITION: JUNIOR/VALIDATION ENGINEER

LOCATION: BENGALURU - HEBBAL

COMPANY : An Industrial Automation Machines Manufacturing

Role & Responsibility/Tasks:

• Ensure the qualification project aligns with the customers requirements if a qualification package is ordered.
• Clarify the customer's qualification requirements during the qualification kick-off meeting.
• Document the agreements from the qualification kick-off meeting in the Qualification Master Plan (QMP).
• Conduct Process Failure Modes and Effects Analysis (PFMEA) for our machine and document it.
• Create test protocols, including Pre-FAT, FAT, SAT, IQ, and OQ.
• Perform the qualification tests (Pre-FAT, FAT, SAT, IQ, OQ) as per the agreements in the QMP and record the deviations and follow up.
• Contact person for the customer and project team in qualification matters.
• Maintain an overview of all DQ and test documents, keep a document status list, stay updated with Pharma Regulatory changes, or scope of the order change and incorporate technical changes into FMEA.

Qualifications / Requirements:

• Education: Diploma/Degree in Mechatronics, Electrical engineering
• 3-6 years of relevant experience in Validation, Qualification at Pharma or Pharmaceutical Machine manufacturing, FMCG, packaging industry.
• Knowledge of Pharmaceutical Regulations (GMP, EMA, FDA, etc,)
• Knowledge on technical data (wiring diagram pneumatic diagram) and basic knowledge in HMI, PLC and types of sensors and its core functions.
• Strong communication and presentation skills.
• Ability to multitask.
• Previous experience with FAT, SAT, IQ, OQ, CSV, VAT, QMP, VMP, Process FMEA.
• Good spoken and written English language skill
• Attention to detail.
• Willingness to Travel.

Remuneration:

• Salary based on experience and industry standards.
• Travel allowance in case of traveling to customer site/Training in Germany.