Validation Engineer II - Logan, UT at Thermo Fisher Scientific

Logan, Utah, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Life SciencesIndustries

Requirements

Bachelor’s degree in quality, science, or engineering fields
3 years in validation engineering
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

Responsibilities

Perform and assist in the validation and certification of computer systems, equipment, procedures, and testing methods
Guarantee site compliance and timely completion of essential tasks to uphold the validation of all GxP systems
Craft and put 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

Skills

Key technologies and capabilities for this role

IQOQPQGxPCAPAValidation ProtocolsRisk AssessmentRegulatory ComplianceSingle-Use ProductsComputer Systems Validation

Questions & Answers

Common questions about this position

What benefits are offered for this position?

Benefits include medical, dental, and vision effective day 1, paid time off, designated paid holidays, retirement savings plan, tuition reimbursement, and employee referral bonus.

Is this a remote position or does it require on-site work?

This role is performed at the Logan, Utah location in an office work environment.

What skills and experience are required for the Validation Engineer II role?

A Bachelor’s degree in quality, science, or engineering fields and 3 years in validation engineering are required, along with outstanding attention to detail, organizational skills, strong communication skills, and competency in Microsoft Office.

What compensation details are provided for this job?

The position offers an annual performance-based bonus and annual merit performance-based increase.

What makes a strong candidate for this Validation Engineer II position?

Strong candidates will have a Bachelor’s degree in quality, science, or engineering, 3 years of validation engineering experience, and demonstrate outstanding attention to detail, organizational skills, strong communication, and proficiency with Microsoft Office.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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