Lab system Validation Engineer

Job Title: Lab system Validation Engineer

Job Location: Schwabenheim, Germany

Job Type: Contract Job Qualifications:

· 10+ years of Lab Systems validation experience is required.

· 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

Job Responsibilities:

· Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems

· Author the 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 type: Contract Experience level: 4 Years Division: eTeam Workforce Limited - Germany Reference: 20-03286