Title: Equipment Qualification Engineer.
Location: Summit, NJ
LOCAL Qualified candidates, please submit resume to: Lisa@patelcorp.com
- Develop Capital Requisitions for new lab equipment & instruments.
- Develop Change Controls for GMP projects
- Work with Engineering and Facilities for pre-installation activities
- Manage vendors for the installation & qualification of new instruments.
- Develop, review, and approve all associated documentation for GMP equipment and software including but not limited to IQ, OQ, PQ, SOPs, URS Documents, Work Practices, and Validation Summary Reports.
- Directly involved in the validation of equipment, instruments, and software in all GMP labs
- Initiate and conduct investigations associated with the installation and qualification of GMP instruments, equipment, and software.
- Involved with FDA, internal, and external Audits.
- Responsible for the implementation and training associated with the new SOPs.
- Develop and execute the following software validation documentation: Software Validation Master Plans, Configuration Specifications, 21 CFR Part 11 Compliance Checklists, Traceability matrixes, Risk Analysis and Mitigation Plans, System Administration SOPs, and Validation Summary Reports.
- Work directly with Summit GMP & Non-GMP laboratories to procure, install, and qualify new equipment and instrumentation.
- Support all instrumentation and equipment calibrations in the laboratories at Summit
- Responsible for reviewing and approving both external and internal maintenance and calibration activities performed by outside vendors or by the Company Validation and Metrology Department.
Laboratory Construction Projects
- Work directly with the end users to develop User Requirement Specifications for the new area.
- Review and approve Basis of Design Documents
- Oversee the construction to ensure user specifications are met
- Initiate any Change Controls associated with the addition of GMP instrumentation or equipment.
- Responsible for the qualification activities associated with new equipment
- Work directly with vendors for procurement of new instruments, contracts/service agreements, and service request calls.
- Responsible for vendor site audits.
HOW TO APPLY:
All candidates who meet the requirements above please send your resume in word format to LISA at the following email. Lisa@patelcorp.com
Please include the following description in the subject line of your email (LMD-AA-ENG)