*Job Title*
*Computer Systems Validation*
*Project Location*
*Northridge, CA*
*Duration*
*6-12+ Months Contract*
*Interview Process: Phone and Skype*
*Visa:* *Any*
*Job Description*:
*MUST HAVE*
• Excellent communication
• Very strong with spread sheet validation
• REAL references
• Must have a LinkedIn profile
*KEYS-*
- *BS Deg & 5+ years validating computer software, spreadsheets, reports
and tools that are used in support of manufacturing medical devices, pharma
or biologics. Search terms may be “CSV” for Computer Sys Validation.*
- *CSV Computer System Validation 5+ years of experience*
- *Validating Spreadsheets and reports. Must be able to lead a team and
speak in front of groups.*
- *Spreadsheet validation exp is key. Validated SAP or Agile, documentum
etc.. Quality system sw applications.*
- Need to have spreadsheet validation experience (spreadsheet validation
is a subset of CSV that the candidate must have some experience with:
spreadsheets, reports, and software systems are all subsets of CSV).
*Notes from call with HM today-*
· Non product software validation
· *5+ years validating computer software, spreadsheets, reports and
tools that are used in support of manufacturing medical devices, pharma or
biologics.*
· Not a sW design engineer.
· Look at a spreadsheet and be able to facilitate a project team in
their validation activities
· This person will NOT be leading any validation activities,
instead be coaching a facilitating and providing SME to project team
leaders. Many will not know about validation.
· *Spreadsheet validation exp is key. Validated SAP or Agile,
documentum etc.. Quality system sw applications.*
*Job Duties:*
- Responsible for reviewing of *Validation deliverables.*
- Facilitates the validation process and drives towards consensus on
validation approach/strategy.
- Provides directions to project team to maintain systems in a validated
state.
- This person will not be writing or establishing standards, they
will be responsible for adhering to standards.
Thanks & Regards,
Udbhav Mathur
Talent Acquisition Specialist
*Tekshapers Inc. *
Ph:248-565-4747 *130
Email:- [email protected] <[email protected]>
*Tekshapers Inc. – WMBE Firm*
*1441 E. Maple Rd, Suite # 301, Troy, MI 48083 *
http://www.tekshapers.com
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