Years of Experience: 2 to 5 years

Dosage Form: Should have worked in Oral Liquid dosage/ Nasal/ Oral Power dosage.

Purpose

He will be responsible for handling shift operations along with key focus on HVAC system, Calibration, qualification, validation activities with continuous QMS compliance.

Job Responsibilities / Deliverables

- Daily verification of HVAC system operation and ensure its continuous compliance to desired parameter. He should also plan trouble shooting and maintenance activity as per requirement based on the technicians feedback and operational log sheet.
- Preparation, review and implementation of engineering systems, operation & maintenance SOPs and IQ/OQ/PQ, qualification, requalification, and validation activities.
- Initiation, execution, review and timely completion of HVAC /Water system / compressed air validation and qualification activities.
- Carrying out preventive and breakdown maintenance of HVAC, purified water pretreatment, generation and distribution system and filter cleaning activity as per schedule. He should also ensure that the equipment remains in healthy condition and shall not lead to breakdown.




- Ensuring continuous compliance of workplace condition of all process and storage area with proper recording and control on EMS and BMS report followed by verification of the record on daily basis.
- Plan and execute calibration of instruments and maintain calibration schedules/records.
- Manage engineering deviations, CAPA, change controls, and investigations and

Coordinate with QA, Production, QC, vendors, and contractors for qualification and validation activities. Qualifications & Pre-Requisites

- Diploma or BE/ B Tech - Electrical / Instrumentation / Mechanical
- Should be able to handle QMS documents.
- Working Exposure to USFDA , MHRA , TGA regulatory approved plants.
- Experience in troubleshooting of all HVAC system and purified water system.
- Exposure to Formulation plant equipment like AHU/ Chillers/ cooling tower/ BMS & EMS system/ Scrubbers/ Dust collectors etc.
- The preferred target companies will be Pharmaceutical Formulation plants.

Additional notes

- Role is expected to work in all shifts.
- Expected to support Thane/ Ambernath site during emergency.
- Will be coordinating with vendors for execution of HVAC upgradation activity as per requirement.

📌 Engineering officer- HVAC & QMS- Satara
🏢 Rubicon Research
📍 Satara