Validation Engineer with Windchill PLM_Plymouth, MN_C2C

Hello Partner,

We have an below immediate position to close in couple of days. Please let me know if you have any consutlant on your bench.

Position: Validation Engineer

Location: Plymouth, MN

 

Requirements :

1. PLM Background preferred. Preference to Windchill PLM
2. Med Device QA work history preferred.  Familiar with Regulated documentation requirements … Val Plans/Test Plans/ and reports etc …
3. Able to define test scenarios, establish Requirements Trace Matrix, and create test scripts
4. Will need to execute test scripts.  Familiarity with Quality Center preferred
5. Good Communication, Organization, and Documentation skills
6. Validation Engineer:
1. Need resource to help with TCE à WC data verification. This is comparing attributes on objects between source system and target system and confirming things mapped over as expected per the mapping rules. Expect this to take 4-5 weeks, then transition into GPR project below.
2. Global Product Registration (GPR) BA/QA project.  New solution being developed to track regulatory licenses, certs, etc.  Mostly QA type work here, Requirements work is mostly being done by solution provider.  Would need to understand solution and requirements and work with project team to develop validation/test plan (as well as test scripts) to test the requirements.
3. Strong knowledge in PLM Product Lifecycle Management.
4. Create test plans, test scripts and test plans.
5. Good understanding in FDA Validation activity.
6. FDA interface, project management and contractor supervision.
7. Strong validation experience in the following areas: Facilities (HVAC/ Environmental Monitoring Program), Utilities (Water Systems), Equipment (Washers, Autoclaves and Fillers), Automated Process Controls, Purification and Compounding Manufacturing Processes, Analytical & Physical Test Methods, Statically Sampling and Process Monitoring (SPC).
8. Familiarity with Windchill 10.2, 11.0 or higher, Bills of Material, Revision Controls and Change Controls.
9. Familiarity in Windchill Change Management, Release Management, Part Management, BOM management, Document Management, Configuration Management.
10. experience with a PLM, PDMLink / PartsLink.
11. Implementing and maintaining the effectiveness of Diagnostic Devices Validation Program for Equipment, Utilities, Facilities, Processes and Test Methods.
12. Functions include: SOP creation/update and review, authorship (protocol, VMPs, etc.), review/ approval of validation deliverables.
13. Experience and proficiency with various web-based software applications including Microsoft Office Word, Excel, PowerPoint, SharePoint, etc.
14. Excellent written and verbal communication skills a must

 

Warm Regards,

 Santosh Kumar,
Technical Recruiter,
Email: santosh@techginia.com

Hangouts: santoshrecruitment99@gmail.com

Website: www.techginia.com

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