Sr Validation Engineer - Altavista, VA Plant

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Production areas that are clean, well-lit and temperature-controlled
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
• Vacation – 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
• Retiree Healthcare program
• Robust 401(k) retirement savings with a generous company match
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A stable company with a record of strong financial performance and history of being actively involved in local communities
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

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 FD