Senior Kneat Validation Engineer RR3502BC

Who are we:

Looking for an exciting opportunity at a fast growing, employee-oriented company? Verista’s 500+ experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

Verista’s experts include SMEs across the spectrum of pharma, medical devices and biotech industries. As a result, we’re uniquely capable of offering transformative, integrated solutions, new perspectives, and consistent results.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable our clients to improve the quality of patient healthcare worldwide. Our talented and dedicated professionals are committed to making an impact every day.

We deliver solutions that are right the first time.

Typical Responsibilities Include:

Kneat Validation Engineer 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.

Requirements

• 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 organization

Preferred:

• Kneat Power User 2 or Super User certification

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Benefits

Because employees are the key to our success, Verista offers strong benefits and incentives including:

• Health, Dental, and Vision Insurance
• 401(k) Retirement Plan with a company match
• Paid Time Off Pay
• Tuition Reimbursement
• 9 Company Paid Holidays
• Paid Long Term & Short Term Disability Insurance
• Training and Development
• Paid Maternity Leave and Parental Leave
• Travel Bonus
• Employee Referral Program
• Tuition Reimbursement
• Marriage Leave
• Bereavement

*Verista is an Equal Opportunity Employer