Engineering Officer - documentation

Sterling Healthcare; Pune District; On-site; INR 420,000 - 780,000; Full time

Job summary

Sterling Healthcare Ltd Talegaon, Pune invites an Engineering Officer to manage maintenance, HVAC systems, and qualification activities at its pharmaceutical manufacturing facility in Talegaon. The role focuses on calibration, IQ/OQ, documentation, GMP compliance, and QMS support.

You will oversee preventive and breakdown maintenance, handle CAPA, risk assessments, and coordinate with production and quality teams to ensure smooth plant operations and regulatory adherence.

Qualifications

• 1-5 years of experience in pharmaceutical engineering.
• Experience in HVAC, maintenance and utility operations.
• Experience with GMP and SOP compliance.
• Knowledge of HVAC qualification & requalification.
• Familiarity with IQ/OQ and calibration.
• Experience with CAPA, change controls, risk assessment.

Responsibilities

• Implement SOPs for engineering systems and ensure maintenance.
• Maintain production machinery, utilities, and water systems.
• Prepare HVAC qualification and requalification protocols.
• Execute temperature mapping and related documentation.
• Verify calibration certificates from external service providers.
• Perform IQ/OQ for new equipment.
• Handle incidents, deviations, CAPA, and risk assessments.
• Perform preventive and breakdown maintenance of plant equipment.
• Monitor AHUs maintenance and utility system performance.
• Maintain GMP-compliant records and SOPs.
• Coordinate with production and quality teams during shifts.

Skills

Pharmaceutical Engineering

HVAC Maintenance

Calibration

IQ/OQ

GMP Compliance

QMS

Documentation

Maintenance Planning

Education

Diploma / BE in Mechanical Engineering

Job description

Engineering Officer

Company Name: Sterling Healthcare Ltd Talegaon ,Pune
Job Title: Engineering Officer
Department: Engineering / Maintenance
Industry: Pharmaceutical
Job Location: Talegaon, Pune, Maharashtra
Experience Required: 1-5 Years
Education: Diploma / B.E. in Mechanical Engineering
Employment Type: Full Time, Permanent

Job Description

Sterling Healthcare is looking for an Engineering Officer to manage engineering maintenance, HVAC systems, utility operations, equipment qualification, calibration, and engineering documentation at its pharmaceutical manufacturing facility in Talegaon, Pune.

The candidate will be responsible for ensuring smooth plant operations, executing preventive and breakdown maintenance, maintaining GMP compliance, and supporting engineering-related Quality Management System (QMS) activities.

Key Responsibilities

• Ensure effective implementation of Standard Operating Procedures (SOPs) and engineering systems.
• Maintain smooth functioning of production machinery, utility equipment, and water systems.
• Prepare, review, and execute HVAC qualification and requalification protocols.
• Execute temperature mapping activities and prepare, review, and maintain related documentation.
• Verify temperature mapping and calibration certificates received from external service providers.
• Perform calibration activities for plant equipment as per approved schedules.
• Prepare, review, and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols and reports for newly installed equipment.
• Handle engineering-related incidents, deviations, change controls, CAPA monitoring, and risk assessments.
• Perform preventive and breakdown maintenance of production, utility, and water system equipment.
• Execute preventive maintenance of Air Handling Units (AHUs) as per schedule.
• Monitor HVAC filter cleaning activities and utility system performance.
• Maintain engineering records and documentation in accordance with GMP and approved SOPs.
• Monitor shift engineering operations and coordinate with production and quality departments.

Required Skills-

• Pharmaceutical Engineering and Maintenance
• HVAC Systems and AHU Maintenance
• HVAC Qualification and Requalification
• Temperature Mapping
• Equipment Calibration
• Installation Qualification (IQ) and Operational Qualification (OQ)
• Preventive and Breakdown Maintenance
• Utility and Water System Maintenance
• GMP and SOP Compliance
• Quality Management System (QMS)
• Change Control, Deviation, CAPA, and Risk Assessment
• Engineering Documentation

Educational Qualification

Diploma or Bachelor of Engineering (B.E.) in Mechanical Engineering.

Experience

1 -5 years of relevant experience in pharmaceutical engineering, plant maintenance, HVAC, or utility operations.