Equipment Qualification Engineer.

for Patel Consultants Corp in Summit, NJ

Report
Skills:
Chemistry degree is preferred 
Location:
Summit, NJ
Area Code:
908 
Travel Req:
none 
Telecommute:
no 
Pay Rate:
TBD 
Tax Term:
CON_CORP 
Length:
 
Posted:
3-2-2015 
Position ID:
177892 
Dice ID:
patel 

Title:  Equipment Qualification Engineer.

Location: Summit, NJ

 

LOCAL Qualified candidates, please submit resume to:  Lisa@patelcorp.com

 

Summary:    

   

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.

Quality/Validation

  • 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.

 

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)

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