Kneat Implementation Engineer / Senior Validation Engineer- 4804

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

Kneat Implementation Engineer Responsibilities:

This position requires advanced learning; technical precision; and consistent use of independent judgment and discretion. Kneat Validation Engineers utilize Kneat Gx and CSV/CQV experience to provide value added solutions to Verista clients.

• Thorough understanding of C&Q and/ or CSV and the ability to apply and implement this knowledge at a client
• Direct experience authoring/editing/executing validation documents
• Can demonstrate the Functional Differences between a Paper Based System and an Electronic System
• Kneat Expert – Process Mapping
• Master of the 3 Kneat Elements
• Transferring document templates to a work folder
• Sharing data across the work process documents
• Modifying documents with templatized sections
• Ability to translate a Work Process into the 3 Kneat Elements
• Ability to coordinate teams to complete validation/Kneat activities

Requirements

• Bachelor’s degree or higher required
• 3-5+ years’ experience in GMP regulated environment
• Ability and willingness to quickly learn new technology
• Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards
• Advanced skills with WORD (authoring/editing large technical documents with styles, template creation, tables, TOCs) ·
• Capacity to make independent sound decisions and independently manage priorities ·
• Proven attention to detail and organization (including technical proofreading, follow-through, and project communication) Experienced at effectively communicating to different levels of the …