Title: LABX Lead/SME
Location: Branchburg, NJ
Pay Rate: $77/hr on C2C
Mandatory Skills:
Experience with major LABX implementation performing the role of LABX Lead/SME
- Detailed JD (Pl share the Detailed Description, 1 liner JD will not work) Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems & LabX (Mettler)
- Author theS typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
- Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPs
- Coordinate alignment of systems users from various company groups on validation and qualification documentation
- Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
- Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders
- Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.
Job Qualifications:
- 7+ years of Lab Systems validation experience is required.10+ years are desired
- Mettler LabX deployment, method development and validation experience (end to end) - pH, balance, titrators, refractometers, melting point and density meters; 2+ years’ experience with LabX method development and validation preferred.
- Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures)
- Understanding of Data Integrity concepts is required
- Excellent communication and written skills required
- Leadership skills: guidance, facilitating and team building.
- Effectively utilize tracking tools: MS Excel, Project, PowerPoint, MS Teams, SharePoint, etc.
- Trained by Mettler Toledo in LabX
- Proactive tracking and follow up on tasks for self and team
- Ability to organize for action and perform
Thanks,
_______________________________________
Govind Singh Kushwah | New York Technology Partners
120 Wood Avenue S | Suite 504 | Iselin NJ 08830
Direct: 201.604.3877 | LinkedIn | www.nytp.com
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