The Validation Engineer II is responsible for performing validation and Engineering activities, conducting development studies, analyzation and assist in improving pharmaceutical systems and processes.
Essential Functions:
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
Additional Responsibilities:
Assists with engineering projects and performs other duties as assigned.
Education:
Bachelors Degree (BA/BS) BS: in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required
Experience:
2 years or more experience in engineering, pharmaceutical industry, cGMP environment
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
Specialized Knowledge:
Read, understand and verify piping & instrument diagram, engineering layout, drawing and documents
