Clean Rooms and Environmental Qualification Engineer Details

Clean Rooms and Environmental Qualification Engineer

splintpharma - Raleigh, NC

Employment Type : Full-Time

Job Opening for Clean Rooms and Environmental Qualification Engineer, Raleigh, NC
Clean Rooms and Environmental Qualification

Onsite
Rate: $35 to $45
Duration: 12mo+

Job Description: Develop and execute Qualification deliverables for clean room systems, including but not limited to Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Trace Matrices, Test Execution, Summary reports.

Requirements:
Education: Bachelor’s degree in Engineering or related science studies.
Prefer five (5)+ years related work experience including strong knowledge and hands-on experience in the regulated industries.
Strong technical writing skills

Essential skills:
Understanding and experience with regulations and guidelines such as USP and FDA;
Strong knowledge in commissioning and qualifying clean rooms (IQ)
Strong knowledge of EM qualifications (PQ)
Experience coordinating with microbiology lab groups for sampling
Experience with air flow visualization