Engineer III, Validation
Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

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.

Excellent Benefits Package

Review our company's Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement - eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

The Engineer III, Validation is responsible for assisting the validation team in supporting all site validation activities. This includes automation equipment, product transfers, new product development, and working collaboratively with various functions to sustain change. The Validation Engineer is an active participant in the origination of design concepts and specifications, process/technology development, product verification/validation, project planning, and other applicable documentation while adhering to quality and manufacturing requirements.

What will you do?

• Serve as the primary interface between Operations and Quality Assurance.
  
• Originate and assist in the preparation and approval of change orders related to the operation and improvement of manufacturing processes.
  
• Assist in maintaining the Site Validation Master Plan.
  
• Support development projects, transfer projects, process changes, and engineering projects to provide overall guidance as it relates to quality standards, inspection techniques and frequencies, statistical analysis, testing, validations, and risk assessments (FMEAs).
  
• Direct and oversee validation activities for Operations, Engineering, Quality Assurance, and other functional areas.
  
• Review, revise, and maintain site validation procedures, qualification protocols, and associated data in accordance with FDA and ISO requirements.
  
• Lead and/or assist in training of staff involved in validation activities.
  
• Assist Quality, Operations, and Engineering personnel during inspections or audits.
  

• Bachelor's degree from a four-year college or university and 5+ years of proven experience or in the pharmaceutical, medical device, or in-vitro diagnostics industry with dynamically increasing responsibilities is required.
  

• Associate degree and 8+ years of relevant experience.
  

• Knowledge of global regulatory and quality requirements associated with medical devices.
  
• Working knowledge of ISO 13485 and 21 CFR Part 820.
  
• Proficient in Microsoft Office Suite.
  
• Experience with formal problem solving in a team environment.
  
• Detail oriented with the ability to lead multiple projects and activities as assigned.
  
• Proficiency with various software platforms such as Minitab, Blue Mountain RAM, and Master Control is preferred.
  
• Excellent organizational, planning, communication, and follow-up skills.