Urgent Need :: Validation Engineer :: Irvine, CA :: 6+ Months Contract

Mail me your updated resume on chandrashekhar.kumar@diverselynx.com

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 – chandrashekhar.kumar@diverselynx.com

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