Judge Technical Staffing

Purpose:

This position provides leadership and direction in the field of metrology; chiefly concerning the calibration of test and measurement equipment used in process development and production applications such as: temperature, flow, conductivity, pressure, physical, and dimensional, etc.

Through effective interaction with client personnel and contract organizations, the Calibration and Validation Specialist is responsible for the development, execution, direction and maintenance of validation programs for instruments, equipment, and other utilities and processes. Responsible for developing and recommending validation strategies and designing studies for the purpose of providing documented evidence that a system, equipment, method, or process has been validated.

Key Responsibilities:

1. Ensures scheduled calibrations are performed within the calibration/validation department and manufacturing/process development department in a timely manner.

2. Develop calibration methods, and facilitate continuous improvement efforts within the department.

3. Review equipment calibration specifications.

4. Provide guidance to others within the laboratory in assessing measurement process variability and uncertainty.

5. Provides timely verbal and written communications with user departments, and engineering.

6. Follow standard calibration procedures per Calibration SOP's.

7. Interprets records and verifies test data, comparing to known standards and criteria.

8. Maintain records within the calibration system.

9. Arrange calibration of equipment at outside calibration service suppliers.                  

10. Identify equipment, instrument, and other validation needs.                                        

11. Responsible for creating requirements, validation plans, protocols, reports and test documentation.                                                                                                                   

12. Review validation documentation created by in-house and/or contract personnel.     

13. Develop and implement solutions to validation issues and recommend quality improvement strategies.                                                                                                      

14.  Maintain and implement validation project schedules.                                               

15. Provide departmental and site management with periodic updates concerning the status of validation activities.                                                                                             

16.  Maintain calibration schedule.                                                                                      

17. Working with contractors in-house and contract personnel, ensure calibrations are performed and documentation is appropriately reviewed.                                                 

18. Maintain all documents in accordance with quality systems.

EDUCATION, EXPERIENCE, and/or SKILLS:

HS Diploma/GED. A minimum of 6 years of calibration/validation experience. The candidate must have working knowledge of current Good Manufacturing Processes (cGMPs), FDA regulations and ISO standards. The candidate must have problem solving skills, and the ability to effectively manage multiple projects. Must possess Microsoft Office computer software applications literacy. Experience with Environmental Monitor System such as Amega System, Rees, etc. Hands on experience with validation of analytical instruments, autoclaves, refrigerators/ freezers.

Please contact:

For immediate and confidential consideration, please send a copy of your resume to ssmith@judge.com

Susan Smith

Scientific/Clinical Recruiter

Fax: 610.784.8201

www.judge.com