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Validation Engineer III

Thermo Fisher Scientific Inc

Detroit, MI

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JOB DETAILS
SKILLS
Biology, Biotech and Pharmaceutical, Cancer, Chemistry, Cleanroom, Communication Skills, Computer Systems, Continuous Improvement, Cross-Functional, Current Good Manufacturing Practice (cGMP), Documentation, Drug Manufacturing, Equipment Validation, FDA Requirements, Food Safety, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Interpersonal Skills, Leadership, Lean Manufacturing, Manufacturing Equipment, Manufacturing Operations, Microsoft Office, Presentation/Verbal Skills, Problem Solving Skills, Process Validation, Project/Program Coordination, Regulations, Regulatory Compliance, Risk Analysis, Root Cause Analysis, Safety Standards, Statistics, Technical Writing, Validation Plan, Willing to Travel, Writing Skills
LOCATION
Detroit, MI
POSTED
30+ days ago

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Join our validation engineering team, where you''ll ensure product quality and regulatory compliance across pharmaceutical manufacturing operations. As a Validation Engineer III, you''ll lead complex validation projects for equipment, processes, utilities, and computer systems while collaborating with cross-functional teams to maintain GMP standards. You''ll contribute to continuous improvement initiatives, support team members, and provide technical expertise during client and regulatory audits. This role offers professional growth opportunities as you help enable life-changing therapies through robust validation strategies and execution.

REQUIREMENTS:

  • Advanced Degree plus 3 years of experience, or Bachelor''s Degree plus 5 years of experience in validation in pharmaceutical/biotech manufacturing or comparable regulated industry
  • Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field
  • Strong knowledge of cGMP regulations, including FDA, EMA and ISO requirements
  • 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
  • Experience leading complex validation projects and coordinating cross-functional teams
  • 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)
  • Experience with regulatory inspections and client audits preferred
  • 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 up to 25% travel

About the Company

T

Thermo Fisher Scientific Inc

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

COMPANY SIZE
10,000 employees or more
INDUSTRY
All
WEBSITE
https://corporate.thermofisher.com/en/home.html

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