Validation Engineer II
📋 Role Overview & Responsibilities
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-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. - 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 - Advanced
Specialized Knowledge
Read, understand and verify piping & instrument diagram, engineering layout, drawing and documents
Frequently Asked Questions
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Is this position eligible for remote work or visa sponsorship? ▼
This position is located in Piscataway, NJ with potential relocation and sponsorship assistance depending on candidate qualifications.
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