Job Title : Validation Engineer
Job Description
Develop validation protocols (IQ and OQ), validation reports, and factory acceptance test documents. Read and interpret electric and pneumatic controls, technical design documents, and PLC code.
Execute field testing of approved validation protocols (IQ / OQ) and commissioning documents, which includes I / O forcing, alarm testing, sequence testing, PLC diagnostics, and PID loop performance testing.
Specify, obtain, and maintain hardware and software necessary for in-house and on-site validation testing. Document test results, record deviations, and resolve deviations.
Prepare field visit documents in a timely and professional manner, including field reports, daily labor logs, invoices, and expense reports.
Present validation results to the customer's project team (QA, validation, project management). Stay current with the latest cGMPs, validation technology and procedures, ISPE guidelines, and related FDA publications.
Hard Skills
- Write and perform validation protocols for pharma process equipment
- Comfortable working hands-on with equipment / machinery
- Good documentation practices
- Understand schematics / engineering documents
Job Type
This is a permanent position.
Work Site
This is a fully on-site position in RAMSEY, New Jersey.
Work Environment
Validation team consists of 4 full-time employees, this hire will make the team 5. The department often experiences peaks and valleys in workloads due to the nature of their business.
All Validation Engineers report to the Validation Engineering Manager. The role involves a 50 / 50 split between document writing and hands-on validation work.
Expect 25-35% travel to customer sites throughout the US, Canada, and Puerto Rico, with travel durations ranging from 2-3 days to 6-10 days depending on project size / scale.
For extended travel, opportunities to return home throughout the project life will be provided when possible.
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