Thermo Fisher Scientific · 5 hours ago
Validation Engineer III
Allentown, PA
Full-time
Onsite
Entry, Mid Level
2+ years expThermo Fisher Scientific is a global leader in serving science, and they are seeking a Validation Engineer III to contribute to their mission of enabling customers to make the world healthier, cleaner, and safer. The role involves providing validation support for computer systems, equipment, and processes, ensuring compliance with Good Manufacturing Practices and preparing necessary documentation.
BiotechnologyMedical DeviceCloud ComputingEnterprise SoftwareConsultingHealthcareLife ScienceBioinformaticsCloud Data ServicesHealth CareManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Interacting with several departments to provide validation support for computer systems, equipment and processes, along with the critical utilities and facilities required for packaging operations at the site
Accountable for preparing and carrying out validation documentation (VP, IQ, OQ, PQ) along with producing the related summary reports
Give to the preparation of Process Performance Qualification (PPQ) documentation, which includes 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 resolve 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 build 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 of Master Plan (VMP) as required
Author SOPs (Standard Operating Procedures) and Validation Documentation within Documentum
Conduct all activities in a safe and efficient manner
Qualification
Required
Knowledge of Computer System Validation (CSV)
Knowledge of Controlled Temperature Unit Operation and Management
PC literacy including the ability to generate sophisticated documents in both Microsoft Excel and Microsoft Word
Effective communication skills
Strong analytical skills
Ability to multitask and respond to shifting priorities
Effective written and verbal interaction abilities
Prior mechanical and process equipment experience
A four-year Bachelor of Science degree in Engineering or Science from an accredited college is required
You must have 2-5 years of validation experience in a regulated industry or equivalent experience. This includes five years in food or pharmaceutical packaging or cGMP experience
Needs to be capable of lifting 35 pounds
Preferred
Proficient with Mini-Tab or similar statistical analysis software
Knowledge of pharmaceutical packaging materials and equipment
Benefits
Competitive remuneration
Annual incentive plan bonus scheme
Healthcare
A range of employee benefits
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Michel Lagarde
Chief Operating Officer
Recent News
Boston Herald
2026-02-07
Company data provided by crunchbase