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Hiring for CSV Engineer Onsite in MD :: All Visa workable at Remote, Remote, USA
Email: [email protected]
Title:- CSV Engineer

Baltimore, MD (Onsite)

All visa

6+ years
of experience needed with strong
MODA skills

Moda is Must

Senior CSV Engineer/Analyst Responsibilities: MODA

Direct experience and understanding of complex automated lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators

Experience with lab system configuration and operation

Understanding of system integrations, including but not limited to understanding of how integrations are designed / constructed, data flow from source systems to target systems,
typical testing approach for system integrations

Independently understanding clients quality standards, cGMPs, and regulatory standards to support team in compliance of validation effort

Independent verification of testing against specifications

Managing and working collaboratively with clients quality representative to complete deviation investigation and resolution for problems and issues encountered during execution
activities. Includes ability to complete root cause analysis

Familiarity with bench top analytical equipment and have worked with chromatography and LIMS system sample workflows

Product Owner/Admin for Micro EM MODA

Oversee delivery of a validated GMP solution to a global user community

Collaborate with site laboratory operations subject matter experts (SMEs) to deliver a solution built upon a harmonized business process aligned with quality standards and
site-specific monitoring procedures.

Oversee root cause analysis and vendor collaboration on technical issues to promote solution performance.

Ability to create a Standard Operating Procedure (SOP) for site master data configuration, migration, and verification.

Support the creation and delivery of global training materials for EM MODA.

Create business requirements and user stories, performing product backlog creation and refinement.

Work with cross-functional teams represented by site, vendor, and global teams to provide on-going support of a user community of practice.

Technical lead responsible for managing enhancement and bugfix testing, validation, and release of EM MODA

Must be willing to work onsite in Baltimore, MD

Bachelors Degree or equivalent required

Demonstrated experience in leading CQV activities specific to Process Equipment

Proficiency using PC and Microsoft Office tools

Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms

Ability to work as part of a team

Strong problem-solving and critical thinking skills

Excellent organizational and time management skills

Strong attention to detail

GMP and Good Documentation Practice

Thanks & Regards

Manish Kumar

Sr.
Technical Recruiter

Email:        

[email protected]

Linkedin:

linkedin.com/in/manish-chaudhary-jaat-21b9011a3

ANVETA, Inc

Address: 1333 Corporate Drive, Suite #108 Irving, TX 75038, USA

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Keywords: information technology green card Maryland Texas
Hiring for CSV Engineer Onsite in MD :: All Visa workable
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Thu Sep 12 22:11:00 UTC 2024

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