Hello,

Hope you are doing well.

This is Bharat from Nityo Infotech. Please find the JD below and if you
have any consultant available then please let me know ASAP at
[email protected].



*Validation Engineer*

*Irwindale**, CA*

*10 months*



   - *Hands on experience on validation in Medical Industry.*
   - *Working knowledge of cGMP guidelines, FDA 21 CFR Part 820/210/211,
   ICH guidelines and other international regulatory requirements*.



*Technical/Functional Skills-*

   - Working knowledge of cGMP guidelines, FDA 21 CFR Part 820/210/211, ICH
   guidelines and other international regulatory requirements.
   - HVAC system Commissioning, control facilities temperature and relative
   humidity mapping, facilities Qualification and Validation activities.
   - Scheduling, planning and execution of validation projects for plant
   utilities, facilities and process equipment.
   - Apply thorough understanding of cGXPs, relevant plans and SOPs,
   routine project procedures, project management activities as appropriate.
   - Plan Commissioning & Qualification activities and track execution of
   C&Q activities/documentation versus project timeline.
   - Write/review C&Q plans, study/test protocols, and summary reports.
   Manage execution of study/test protocols and review test results.
   Commissioning and qualification protocol execution, and manage protocol
   deviations, investigation and corrective action activities
   - Have excellent analytical skills with systematic approaches to problem
   solving.
   - Demonstrate ability to comprehend mechanical/electrical drawings and
   related engineering prints for C&Q activities.

The position requires a combination of sedentary work and walking around
the cGMP manufacturing facility.

*Generic Managerial Skills-*

   - Ability to communicate effectively at all levels in verbal and written
   form, including technical/business writing.
   - Proficient in Microsoft Word and Excel, Project and other desktop
   computing software.
   - Able to establish and manage multiple cross-functional teams.
   - Project management experience preferred.


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[image: Description: cid:[email protected]]



Nityo Infotech Corp.
666 Plainsboro Road,

Suite 1285

Plainsboro, NJ 08536



*Regards*



*Bharat Chhibber*
Desk : 6098530818 Extn 2111

Fax : 609 799 5746
*[email protected] <[email protected]>*


------------------------------

USA | Canada | India | Singapore | Malaysia | Indonesia | Philippines |
Thailand  | UK | Australia / Zealand
------------------------------

*Nityo Infotech has been rated as One of the top 500 Fastest growing
companies by INC 500*
------------------------------

*Disclaimer:* http://www.nityo.com/Email_Disclaimer.html
------------------------------

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