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Title : ALG- Sterilization Engineer -694
State : Texas   Date : Jun 29, 2022
Experience Level :  
Position Type : Sterilization Engineer      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Fort Worth, TX  

Job Title: Sterilization Engineer

Duration: 20+ months (extendable) contract on W2


Duties:

a. Supports and collaborates with the project team for validation efforts right from inception, design build, test and implementation
b. Investigate/troubleshoot validation discrepancies for systems and/or performance processes
c. Author and coordinate validation protocols– IQ/OQ/PQ
d. Support ethylene oxide requalification activities to meet ISO requirements on time
e. Create change controls and provide assistance in determining root cause for non-conforming events and evaluate CAPAs for effectiveness
f. Ensures required processes and procedures are followed to support validation programs and are in compliance with regulations
g. Co-operates with all departments through open, candid communication and collaboration
h. Knowledge of statistical analysis to assess control and manage risks of product quality and determine the responsibility for products or materials that do not meet required standards and specifications.

Skills:

a. 1-3 years working experience in medical device manufacturing or similar GMP environment
b. Prior experience working with ethylene oxide and gamma sterilization processes
c. Pharmaceutical Industry GMPs. Interpret & Apply ISO 11135, 11137, TIR 15, TIR 28, 11737 and FDA and Country specific guidelines to the medical devices and surgical.
d. Good communication skills and able to lead a team.

Education:

Bachelors Degree ( Microbiology/Biology/Physics/ Chemistry) or relevant discipline or equivalent.



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com
NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
4390 US-1, Suite 110 
Princeton, NJ 08540
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