Validation Engineer

Role Summary

The Validation Engineer is responsible for performing validation and Engineering activities, conducting development studies, analyzation and assist in improving pharmaceutical systems and processes.

Responsibilities

• Design, review and execute validation document activities such as Factory acceptance test (FAT), Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for equipment/utilities/facilities and generate reports which summarize results, specification and its acceptance criteria
• Performs re-qualification of equipment, facility and utilities as required
• Responsible for creating validation project and validation progress reports - weekly and monthly
• Participate in evaluation of failures and out of specification results impacting compliance with quality, safety and other design requirements
• Provide Technical Inputs and develop strategy for various domestic and international Site Transfer projects. Provide regular status updates to the department and program management.
• Closely works with the maintenance & facility teams to complete new equipment installation, commission and validation as per project requirement.
• Performs engineering assessment and writes investigation reports for non-conformance
• Assists with engineering projects and performs other duties as assigned.

Qualifications

• 2-5 years experience in engineering, pharmaceutical industry, cGMP environment

Education

• Bachelors Degree (BA/BS) in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required

Skills

• Proficient in MS Office. - Advanced
• Excellent technical writing skills - Intermediate
• Excellent oral and written communication skills. - Advanced
• Must be able for follow direction and execute assigned work independently, after initial training is completed - Advanced
• Ability to work both independently and in conjunction with a team - Advanced
• Read, understand and verify piping & instrument diagram, engineering layout, drawing and documents