CSV Engineer/Analyst - Senior Validation Engineer - 4844

Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

CSV Engineer/Analyst Responsibilities:

Review all IT CSV project and system deliverables including but not limited to:

1. Plans
2. Requirements
3. Specifications
4. Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etc.)
5. Summary Reports
6. Change Controls

Review system operational and administration procedures to ensure they are adequate

1. Document any findings of non-compliance
2. Assist with strategy regarding remediation activities
3. Assist with review of remediation activities

Additional Potential Responsibilities

• Provide IT CSV support to implement and validate electronic systems in accordance with corporate policies and procedures
• Collaborate to gather business needs and utilize appropriate tool for tracking of the work allocated
• Provide regular reporting of project timelines, issues/escalations and other metrics/KPIs
• Work directly with the business, validation team and other stakeholder groups for implementation, operational and development changes for the given systems
• Assist in the review of change controls and associated tasks. Effectively assist to project manage projects to completion
• Review and provide feedback/approval on risk assessments, Validation Plans, Specifications, Test scripts, Installations Qualification Protocols, Operational Qualification Protocols, Performance Qualifications Protocols, Trace Matrices and Summary Reports associated with validated computer systems
• Engage in Quality process improvement initiatives, as applicable
• Review and approval of defined life cycle deliverables in compliance with the governing regulations and procedures.
• Perform supporting quality related activities associated with computerized systems including review of change controls and test runs when applicable
• Provide guidance to project teams on compliance requirements for the given project as it relates to activities within scope
• Perform all assigned and required trainings to maintain 100% compliance

Requirements

• Must be willing to work onsite in either Durham, NC or Elkton, VA
• Must have CSV QA experience, with the ideal candidate having performed the final QA signature on the entire SDLC documentation suite
• Delta V experience
• Strong Data Integrity knowledge; knowledge of principles, how to apply them, and how to improve and implement data integrity
• 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
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change
• Experience in GMP regulated environment
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship

Benefits

Why Choose Verista?

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performan