Validation Engineer
Amneal Pharmaceuticals
Full-time
On-site
Piscataway, NJ
$70,000 - $110,000 USD yearly
Operations
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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