Lab Instrumentation/Validation Specialist

2 days ago

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

Abbott Laboratories 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.

Job Summary

We are seeking a highly skilled Lab Instrumentation/Validation Specialist to join our team at Abbott Laboratories. As a key member of our Quality Assurance team, you will be responsible for ensuring instrument validations, maintenance, and troubleshooting adhere to Abbott's Quality System and support the development of high-quality products that improve people's lives.

Key Responsibilities
  • Provide validation and instrument expertise as a Subject Matter Expert
  • 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
What We Offer

At Abbott Laboratories, we offer a competitive compensation package, including a base pay of $29.35 - $58.75 per hour, with opportunities for growth and development. We also offer a comprehensive benefits package, including medical, dental, vision, wellness, and occupational health programs, as well as a 401(k) retirement savings plan with a generous company match.

We are an equal opportunity and military/veteran-friendly employer, committed to employee diversity. If you are a motivated and detail-oriented individual with a passion for quality and innovation, we encourage you to apply for this exciting opportunity to join our team at Abbott Laboratories.

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