Validation Engineer III at Thermo Fisher Scientific

Allentown, Pennsylvania, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotech, Life SciencesIndustries

Requirements

A four-year, Bachelor of Science degree from an accredited college or university in an Engineering or Science field
2-5 years of validation experience in a regulated industry or equivalent validation experience including five years of food or pharmaceutical packaging or cGMP experience
Knowledge of Computer System Validation

Responsibilities

Responsible for the preparation and execution of validation documentation (VP, IQ, OQ, PQ) as well as the generation of corresponding summary reports
Support the generation of Process Performance Qualification (PPQ) documentation, including Control Strategy, Product Knowledge assessment, Process Failure Modes and Effects Analysis, Validation Strategy, and PPQ
Generate, complete, and review protocols for controlled temperature units (Freezers and Coldrooms) and packaging equipment
Perform risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment, processes, materials, and facilities
Conduct all work according to governing SOPs and cGMPs (current Good Manufacturing Practices)
Analyze the results of testing and determine the acceptability of results against pre-determined criteria
Identify protocol discrepancies from established product or process standards and provide recommendations for resolving them
Work closely with engineering to coordinate and complete Factory Acceptance Testing (FAT) activities and protocols
Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols
Coordinate with other departments or outside contractors/vendors to complete validation tasks
Assist with identification and execution of Validation Master Plan (VMP) as required
Demonstrate and promote the company vision of the 4 I’s: Integrity, Intensity, Innovation and involvement
Author SOPs (Standard Operating Procedures) and Validation Documentation within Documentum
Conduct all activities in a safe and efficient manner
Other duties may be assigned to meet business needs

Skills

Validation

GMP

Computer Systems Validation

Equipment Validation

Process Validation

Packaging Operations

Utilities Validation

Facilities Validation

Project Management

PPE

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.

Land your dream remote job 3x faster with AI

Try Jobo Free