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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.
- Positive 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.

📌 Validation Engineer (Bengaluru)
🏢 Nextup Hr Consulting
📍 Bengaluru