MANSFIELD, MA, USA
16 hours ago
UDI Printer Validation
Job Seekers, Please send resumes to resumes@hireitpeople.com Primary Skills: Experience with validation implementation. 
Description:-

Client is seeking Resources to Validate Printer Equipment - Intermec and BELL-MARK printers and LVS barcode verifiers. 
Candidate MUST have experience validating printers in Med Dev companies. 

-Location: Mansfield MA and 75% travel to other company sites 

Job Description 
• Develop system validation scripts based on software/hardware configuration for enterprise systems 
• Work with facility Subject Matter Experts to document user requirements 
• Update application system User Requirements, Functional, and Design Specifications 
• Develop Installation Qualifications based on Design 
• Develop Operation Qualifications based on functional requirements 
• Develop Performance Qualification scripts based on configuration 
• Route validation documentation 
• Manage Tasks based on aggressive timelines 
• Interact with customers at multiple sites 
• Interact in team environment 

Qualifications 
• Experience with validation implementation. 
• Minimum BA / BS or relevant work experience in information systems, 
engineering, science or business. 
• Validation experience with computerized systems in the pharmaceutical industry. 
• Excellent oral and written communication skills. 
• Strong technical background - familiar with writing queries 
• Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practice. 
• Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices. 
• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems. 
• Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner. 
• Ability to work independently with minimal supervision. 
• Adhere to timelines 
• Quick learner 
• Experience with SharePoint 
• Expert in MS Word 
• Able to multitask
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