Thermo Fisher Scientific · 4 days ago
Validation Engineer III
Frederick, MD
Full-time
Onsite
Mid, Senior Level
$83K/yr - $128K/yr
2+ years expThermo Fisher Scientific is a company that partners with pharmaceutical and biotech customers to ensure the right patients get the right therapies. As a Validation Engineer III, you will provide validation support for computer systems, equipment, and processes, ensuring compliance and maintaining validated states.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Responsible for the preparation and execution of validation documentation (VP, IQ, OQ, PQ) as well as the generation of corresponding summary reports
Position will 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 resolve acceptability of results against pre-determined criteria
Identify protocol discrepancies from established product or process standards and provide recommendations for resolving them
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
Demonstrates and promotes the company vision of the 4 I’s: Integrity, Intensity, Innovation and involvement
Author SOPs (Standard Operating Procedures) and Validation Documentation within Documentum
Conducts all activities in a safe and efficient manner
Other duties may be assigned to meet business needs
Qualification
Required
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 (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
Must have strong analytical skills
Needs to be capable of multitasking and responding to shifting priorities
Must have good communication skills, both written and verbal
Must be results oriented
Must have prior mechanical and process equipment experience
Able to lift 40 lbs. without assistance
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Cold Room/Freezers -22degreesF/-6degrees C
Laboratory Setting
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Preferred
Knowledge of pharmaceutical packaging materials and equipment
Benefits
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
Company data provided by crunchbase