Senior Quality Engineer - Validation & Sterile Systems

Sun Pharmaceutical Industries, Inc.; Hinoba-an; On-site; PHP 3,440,000 - 5,316,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd. is seeking an EXE / Sr. EXE – QE (Validation) to lead qualification activities for autoclaves, isolators and tanks. The role requires hands-on validation with IQ/OQ/PQ and deep exposure to sterile pharma environments.

Educational background includes B.E. (Mech.), B. Pharm. or M. Pharm. The position emphasizes project execution, QMS documentation, and collaboration to ensure compliance.

Qualifications

• B.E. (Mech.) or B.Pharm. or M.Pharm. required.
• Experience in validation activities and sterile manufacturing helpful.
• Knowledge of IQ/OQ/PQ processes and QMS tools.

Responsibilities

• Qualification/ design IQ/OQ/PQ for autoclave, isolators, tanks.
• Exposure to water systems, pharma skid, sterile equipment.
• Involvement in project activities in pharma plants as executor.
• Hands-on thermal validation including sterilization, SIP, Lyo, HVAC.
• Investigations and report writing using QMS (e.g., TrackWise).
• Operate Ellab and Kaye validator systems; work in sterile facility.

Skills

IQ/OQ/PQ

Autoclave validation

Thermal validation

Sterile manufacturing

QMS exposure

Project coordination

Education

B.E. (Mech.)

B. Pharm.

M. Pharm.

Tools

Ellab system

Kaye Validator

SIP

Lyo system

HVAC system

Job description

Sun Pharmaceutical Industries Ltd. is seeking an EXE / Sr. EXE – QE (Validation) to lead qualification activities for autoclaves, isolators and tanks. The role requires hands-on validation with IQ/OQ/PQ and deep exposure to sterile pharma environments.

Educational background includes B.E. (Mech.), B. Pharm. or M. Pharm. The position emphasizes project execution, QMS documentation, and collaboration to ensure compliance.