CSV Engineer

Job Roles/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.
• Support the review & approval of key quality deliverables including SDLC, Change control, Deviations, CAPAs. Etc.
• Attend periodic review meetings, cutover migration, hyper care support, any enhancements planning, design and/or implementation meetings as required.
• Good at customer handling and liaising with all stakeholders.

Qualifications & Education:

• 5+ 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
• You have strong analytical skills and an aptitude for decision-making
• You show resilience when faced with challenges
• You believe in continuous learning and growth