Description: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 criteriaPerforms re-qualification of equipment, facility and utilities as requiredResponsible for creating validation project and validation progress reports weekly and monthlyParticipate in evaluation of failures and out of specification results impacting compliance with quality, safety and other design requirementsProvide 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-conformanceAdditional Responsibilities:Assists with engineering projects and performs other duties as assigned.Qualifications ExternalEducation:Bachelors Degree (BA/BS) BS: in Pharmaceutical manufacturing, Engineering, Science or relevant field RequiredExperience:2 years or more in 2-5 years experience in engineering, pharmaceutical industry, cGMP environmentSkills:Proficient in MS Office.
AdvancedExcellent technical writing skills IntermediateExcellent oral and written communication skills.
AdvancedMust be able for follow direction and execute assigned work independently, after initial training is completed AdvancedAbility to work both independently and in conjunction with a team AdvancedSpecialized Knowledge:Read, understand and verify piping & instrument diagram, engineering layout, drawing and documents