Validation Engineer II - Logan, UT

Logan, UT, US • Posted 60+ days ago • Updated 3 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • SAFE
  • Testing
  • Regulatory Compliance
  • GxP
  • IQ
  • OQ
  • PQ
  • Documentation
  • Collaboration
  • Research and Development
  • Quality Assurance
  • Manufacturing Engineering
  • Corrective And Preventive Action
  • ROOT
  • Continuous Improvement
  • Science
  • FOCUS
  • Verification And Validation
  • Computerized System Validation
  • Attention To Detail
  • Organizational Skills
  • Communication
  • People Skills
  • Microsoft Office

Summary

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer!

Location/Division Specific Information:

This role is in the Single Use Division and will be performed at our Logan, Utah location.

How You Will Make an Impact:

As a Validation Engineer II, you will perform and assist in the validation and certification of computer systems, equipment, procedures, and testing methods. Your responsibilities will include guaranteeing site compliance and timely completion of essential tasks to uphold the validation of all GxP systems.

A Day in the Life:
  • Skilled in crafting and putting into action validation activities for software, equipment, products, and processes for single-use products.
  • Formulate, carry out, and understand validation protocols (IQ, OQ, PQ).
  • Review validation data, craft validation reports, and guarantee documentation aligns with regulatory standards.
  • Collaborate with R&D, Quality Assurance, Manufacturing Engineering, and Operations to align validation activities with project timelines and regulatory requirements.
  • Engage in risk evaluations and guarantee that validation tasks address recognized risks.
  • Support the CAPA process by pinpointing root causes of validation issues, implementing corrective actions, and validating their effectiveness.
  • Support continuous improvement initiatives by improving validation processes and procedures.
  • Assist in specification approvals.

Education:

Bachelor's degree in quality, science, or engineering fields.

Experience:

Required: 3 years in validation engineering.

Primary focus on computer software validation (CSV).

Knowledge, Skills, Abilities:
  • Outstanding attention to detail and organizational skills to handle time and prioritize tasks.
  • Strong verbal and written communication skills, and people skills to establish and maintain effective working relationships.
  • Competency in using computers and Microsoft Office products

Physical Requirements and Work Environment:

Office Work Environment

What We Offer:
  • Annual performance-based bonus
  • Annual merit performance-based increase

Excellent Benefits:
  • Benefits & Total Rewards | Thermo Fisher Scientific
  • Medical, Dental, & Vision benefits - Effective Day 1!
  • Paid Time Off & Designated Paid Holidays
  • Retirement Savings Plan
  • Tuition Reimbursement
  • Employee Referral Bonus
  • Career Advancement Opportunities
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10286239
  • Position Id: 5d3ff13900bfdb9f9a4f6540ab5a279f
  • Posted 30+ days ago
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