Thermo Fisher Scientific · 2 days ago
QC Validation Engineer III
Detroit, MI
Full-time
Onsite
Mid, Senior Level
3+ years expThermo Fisher Scientific is a global leader in serving science, dedicated to helping customers find cures for cancer and ensuring safety in various sectors. The QC Validation Engineer III will ensure product quality and regulatory compliance across pharmaceutical manufacturing operations while leading complex validation projects and collaborating with cross-functional teams.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
Responsibilities
Ensure product quality and regulatory compliance across pharmaceutical manufacturing operations
Lead complex validation projects for laboratory equipment, analytical test methods, equipment, processes, utilities, and computer systems
Collaborate with cross-functional teams to maintain cGMP standards
Contribute to continuous improvement initiatives, support team members providing technical expertise
Qualification
Required
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Minimum Required Education: Bachelor of Science (BS) degree in Science or Technical field
3+ years of validation experience in a lab environment
Experience leading complex validation projects and coordinating cross-functional teams
Strong knowledge of cGMP regulations, including FDA, EMA and ISO requirement
Experience writing and executing validation protocols, including IQ/OQ/PQ documentation
Expertise in risk assessment methodologies and statistical analysis
Proficiency with validation of manufacturing equipment, utilities, cleaning processes and computer systems
Strong technical writing and documentation skills
Advanced problem-solving abilities and root cause analysis experience
Excellent verbal/written communication and interpersonal skills
Proficiency with relevant software tools (MS Office, statistical packages, validation systems)
Knowledge of lean manufacturing and continuous improvement methodologies
Ability to work in cleanroom environments when required
Flexibility to work extended hours or alternate shifts based on project needs
May require travel on as needed basis
Preferred
Manufacturing validation experience is a plus
Experience with regulatory inspections and client audits preferred
Benefits
Competitive remuneration
Annual incentive plan bonus
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
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
Marc Casper
CEO
Stephen Williamson
Senior Vice President and Chief Financial Officer
Recent News
2026-01-21
Company data provided by crunchbase