*Mail me your updated resume on [email protected]
<[email protected]>*


Hello,

We are currently looking for “*Validation Engineer”*.

Please find the Job description below and contact me at your earliest
possible convenience.



*Role: Validation Engineer*

*Duration: **6+ Months*

*Location: Irvine, CA*



*Required:*

*Technical 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.

*Experience Required     *

•        Medical devices and process validation experience





Thanks and Regards,



Chandrashekhar Kumar

Technical Recruiter

Diverse Lynx, LLC

Phone: 732-452-1006  Extn 265

Fax: 732-452-0684

Email – [email protected]

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