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Lab Instrumentation/Validation Specialist

1 month ago

Tipp City, Ohio, United States Abbott Full time
About Abbott

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, providing innovative solutions that improve health outcomes and enhance the quality of life for individuals and families around the world.

The Opportunity

This position works out of our Tipp City, OH 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.

Key Responsibilities
  • Provide validation and instrument expertise as an SME
  • Train or coordinate training for Analytical Chemists on instrument procedures and troubleshooting
  • Provide overall support for laboratory instrument health management to ensure uninterrupted testing capabilities
  • Manage instrument maintenance, validations, and troubleshooting
  • Communicate with instrumentation vendors and ensure contracts are up to date
  • Create a prioritized support schedule of current and upcoming laboratory instrument maintenance, validation requirements, and change requests with status and issue to cross-functional stakeholders
  • Maintain positive work relationships; track and communicate with users on milestone status through closeout; periodic review and updates with supervisor
  • Complete all assigned project and documentation updates per committed timelines while maintaining a high quality of work
  • Collaborate and assemble documentation change updates of global method reference documents within validation system (M-Files)
  • Participate in CAPA investigations for PNC/Nonconformities from out of specification results associated with instrumentation and instrumentation validation
  • Review change request compliance against internal policies and procedures
  • Share project updates with a cross-functional team and management
  • Review, update, and communicate testing methods as required
  • Audit testing results as required/directed by manager or supervisor
Requirements
  • 1 year of college science (e.g. chemistry) with appropriate labs and 1 year of college math (algebra, geometry, trigonometry, or calculus)
  • 2+ year of related industry experience
  • Strong understanding of analytical instrumentation and test methods
  • Understanding of Good Documentation Practices
  • Ability to summarize project updates and elevate items of concern to supervisor
  • Prioritize time and multiple priorities with minimal supervision
  • Ability to schedule, set agendas for, and lead meetings with cross-functional stakeholders and scientific experts
  • Excellent written and verbal communication skills
  • Strong attention to detail and results-oriented to meet timelines
  • Ability to effectively communicate to a diverse group of validation system users and share guidance to help users navigate the various instrument systems and process
Preferred Qualifications
  • B.S. or B.A. Degree in a science or technical discipline
  • Familiarity with validation systems (M-Files a plus) and documentation change control in a cGMP setting
  • Familiarity with scientific terminology related to nutrition environment
  • Familiarity with revision tracking and document change control
  • Instrumentation software such as LIMs and Empower
About Abbott's Culture

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 plan
  • Health care and well-being programs, including medical, dental, vision, wellness, and occupational health programs
  • 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