Staff Validation Engineer at Thermo Fisher Scientific

Santa Clara, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Bioprocessing, Life Sciences, BiotechnologyIndustries

Requirements

Bachelor’s degree (or equivalent experience) in Engineering, Computer Science, or related technical field
Master’s degree preferred
Advanced degree or professional certification in validation, automation, or quality preferred
7+ years of validation experience within biotechnology, pharmaceuticals, or regulated manufacturing environments
Proven success leading sophisticated qualification projects from planning to closeout (FAT, SAT, IQ/OQ)
Proven track record to mentor, coach, and influence others across multiple teams
Hands-on experience with automation systems such as DeltaV, PLC/SCADA, or similar platforms
Experience implementing Computer System Validation (CSV) programs and using digital validation tools (ValGenesis, Kneat)
Track record of improving processes and standardizing validation documentation
Strong understanding of GAMP 5, cGMP, GDP, and 21 CFR Part 11 compliance frameworks
Strong understanding of New Product Introduction (NPI) process and product life cycles
Excellent communication and technical writing skills, with a focus on clarity and collaboration
Ability to navigate complex problems and propose practical solutions
Skilled in Microsoft Office and familiar with scripting tools or VBA for data analysis and automation
Adaptable, collaborative, and energized by working in a dynamic and multi-functional environment
Able to lift 40 lbs. without assistance
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Ability to work in laboratory setting, office, with some degree of PPE (safety glasses, gowning, gloves, lab coat, ear plugs etc.), and at heights

Responsibilities

Lead and define validation strategies for TruBio software and bioprocessing systems, aligning with cGMP, GAMP 5, and customer expectations
Serve as the technical lead for qualification and validation, providing direction to project teams across Integration, Field Service, Software, and Quality functions
Develop and approve key validation deliverables—including risk assessments, master plans, FAT/SAT/IQ/OQ protocols, and final summary reports—for both standard and custom systems
Champion collaboration with customers, leading Factory Acceptance Testing (FAT) and supporting audits with confidence and technical expertise
Drive innovation and continuous improvement, finding opportunities to simplify validation processes, automate documentation, and strengthen quality systems
Coach and mentor engineers, promoting a culture of learning, technical excellence, and proactive problem-solving
Lead investigations into deviations and complaints, ensuring timely and effective root cause analysis and corrective actions
Partner with leadership to establish guidelines and validation standards that support digital transformation initiatives like ValGenesis or Kneat
Contribute to organizational strategy by aligning validation processes with business goals and customer needs

Skills

cGMP

GAMP 5

Validation Strategy

Risk Assessments

FAT

SAT

Root Cause Analysis

Factory Acceptance Testing

ValGenesis

Kneat

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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