Engineering officer- HVAC & QMS- Satara

Rubicon Research; Satara; On-site; INR 391,000 - 614,000; Full time

Job summary

Rubicon Research in India is seeking a skilled engineer to join our shift operations team with a focus on HVAC systems, calibration, qualification and validation activities, ensuring strict QMS compliance.

The role includes troubleshooting and preventive maintenance of HVAC and purified water systems, coordination with QA, Production, QC, vendors, and contractors, and supporting upgradation projects across Thane/Ambernath-like sites when needed.

Qualifications

• Diploma or BE/BTech in Electrical, Instrumentation or Mechanical engineering.
• Experience in HVAC and purified water systems.
• Exposure to USFDA, MHRA, TGA regulatory plants.
• Experience handling QMS documents.
• Willingness to work across shifts and coordinate with vendors.

Responsibilities

• Daily verification of HVAC operation and ongoing parameter compliance.
• Prepare, review and implement engineering SOPs and IQ/OQ/PQ qualification and validation activities.
• Initiate and complete HVAC, water system, and compressed air validation tasks.
• Carry out preventive and breakdown maintenance of HVAC, water pretreatment, and distribution systems.
• Ensure EMS and BMS environment condition records are properly maintained.
• Plan and execute instrument calibration and maintain calibration schedules.
• Coordinate deviations, CAPA, change controls, investigations; liaise with QA, Production, QC, vendors and contractors for qualification/validation.

Skills

QMS documents

HVAC troubleshooting

Regulatory exposure

Water systems

Education

Diploma or BE/ BTech - Electrical / Instrumentation / Mechanical

Job description

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 environment 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.