Validation Engineer II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Location/Division

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

About the Role

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!

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:

Benefits

• Annual performance-based bonus
• Annual merit performance-based increase
• Medical, Dental, & Vision benefits
• Effective Day 1!
• Paid Time Off & Designated Paid Holidays
• Retirement Savings Plan
• Tuition Reimbursement
• Employee Referral Bonus
• Career Advancement Opportunities

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Equal Opportunity Statement

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.