Overview
On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 12 Month(s)
No Travel Required
Skills
Biotechnology
Manufacturing
URS
FRS
DDS
Validation
Validation Engineer
commissioning
protocols
FDA
GDP
IOQ
21CFR 210
21CFR
Good Manufacturing Practice
Pharma
Life Sciences
Job Details
Position Summary:
The Validation Engineer is responsible for development and execution of validation and commissioning protocols for general equipment in Biopharma facility. The position requires general knowledge of Biopharmaceutical equipment, cGMP, and GDP. This position is 100% onsite with no remote work.
Duties:
The Validation Engineer is responsible for development and execution of validation and commissioning protocols for general equipment in Biopharma facility. The position requires general knowledge of Biopharmaceutical equipment, cGMP, and GDP. This position is 100% onsite with no remote work.
Duties:
- Perform and support execution of validation protocols/projects
- Develop, review, and redline URS/FRS/DDS
- Support change management process
- Support project level customer communications and coordination efforts
- Prepare and execute commissioning documents
- Prepare and execute IOQ documents and summary reports
- Bachelor s degree in engineering, science, or related field with at least (3) years of experience or Master s degree in engineering, science, or related field with two (2) years of experience in equipment qualification in Biotechnology or Pharmaceutical cGMP environment
- Must possess a solid understanding of FDA validation guidelines, GDP, and industry best practices and be able to implement validation standards daily
- Experience with parts washers and cleaning validation is highly desired
- Familiar with various equipment used in pharmaceutical/biotech manufacturing areas
- Experience with change control process in pharmaceutical industry
- Working knowledge of 21CFR 210, 211 and Part 11
- Excellent organizational, communication, and people skills
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.