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
bhara...@nityo.com.



*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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Nityo Infotech Corp.
666 Plainsboro Road,

Suite 1285

Plainsboro, NJ 08536



*Regards*



*Bharat Chhibber*
Desk : 6098530818 Extn 2111

Fax : 609 799 5746
*bhara...@nityo.com <bhara...@nityo.com>*


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

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