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Sr Validation Engineer - Altavista, VA Plant

Abbott
Raleigh, North Carolina, United States
Full-time

The Opportunity

This position works out of our Altavista, VA location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active.

Millions of people around the world count on our leading brands including Similac, PediaSure, Pedialyte, Ensure, and Glucerna to help them get the nutrients they need to live their healthiest lives.

Altavista, Va. , is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production.

Working here will make you feel like you’re part of a family that works together to make a difference and help nourish millions of families around the world.

What You’ll Work On

  • Lead validation efforts for concurrent medium-to-large size capital projects for Abbott Nutrition Altavista
  • Provide technical expertise in developing Validation Plans, User Requirements Specifications (URS), System Impact Assessments, Risk Assessments (e.

g., FMEA), and Qualification documents.

  • Partner with Engineering, Production and Quality Assurance staff to achieve successful implementation of new and upgraded systems.
  • Keep validation projects within expected scopes and meet specified timelines.
  • Select and guide the efforts of external Validation Service Providers (VSPs) as needed.

You’ll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.

Required Qualifications

  • Bachelor’s degree in Life Science, Engineering, or closely related discipline is required.
  • 5+ years’ experience in commissioning, qualification and validation (preferably with bulk liquid processing, aseptic processing, Clean-In-Place (CIP), evaporation, spray drying, dry blending, and / or powder handling unit operations in the food / pharma / nutrition industries).
  • Strong technical writing ability to explain complex situations in an easy to understand manner.
  • Strong communication and interpersonal skills ability to interact with employees at various levels of the company (from contingent workers up to division directors / VPs.)
  • Strong understanding of Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP) and 21 CFR Part 11.
  • Proficient with Microsoft Word, Excel and Outlook for planning, reporting and collaborating.

Preferred Qualifications

Familiarity with GAMP5 and FDA’s Computer Software Assurance initiatives are preferred.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

26 days ago
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