Equipment Qualification Engineer.

for Patel Consultants Corp in Summit, NJ

Chemistry degree is preferred 
Summit, NJ
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Title:  Equipment Qualification Engineer.

Location: Summit, NJ


LOCAL Qualified candidates, please submit resume to:




Job Description


Project Management

  • 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.

Information Technology

  • 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.

Laboratory Support

  • 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

Vendor Relations

  • Work directly with vendors for procurement of new instruments, contracts/service agreements, and service request calls.
  • Responsible for vendor site audits.


All candidates who meet the requirements above please send your resume in word format to LISA at the following email.

Please include the following description in the subject line of your email (LMD-AA-ENG)

Lisa D
Patel Consultants Corp
1525 Morris Ave
Union, NJ 07083
Phone: (908) 964-7577
Fax: (908) 964-3176