Engineer III, Validation
Thermo Fisher Scientific

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.

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 as part of a cross-functional team responsible for sustaining 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.

Job Description:

• 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 the validation team 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.
  
• Performs other duties as assigned by Staff Validation Engineer and direct manager.
  

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

• Associate degree and 8+ years of relevant experience in the pharmaceutical, medical device, or in-vitro diagnostics industry.
  

• 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.
  

• Normal office and manufacturing environment.
  
• Position may require frequent communication and walking to other areas in which designated PPE will be required.
  
• Position will require sitting and standing.
  
• Employee may occasionally lift and/or move up to 25 pounds.
  

• Must be proficient on validation protocol development, technical writing, data analysis, and report generation. i.e.; IQ, OQ, PQ, FAT, SAT as an example.
  
• Must have knowledge of process + packaging equipment, and software validation principles and concepts.
  
• Must have high level of expertise concerning current validation principles and regulatory requirements.
  
• Strong understanding and proficiency in cleaning validation and cleaning process design.
  
• Must be proficient in statistical analysis and process control.
  
• Ability to influence and coordinate activities of personnel over which he/she has no direct authority.
  
• Must possess strong organizational skills.
  
• Ability to effectively communicate with all levels of the organization, from the General Manager to the production operators.
  
• Ability to resolve conflicts between requests for process change and the validation requirements for those processes.
  
• Proficiency with various software platforms such as Minitab, Blue Mountain RAM, and Master Control is preferred.
  
• Independent self-starter who is capable of planning schedules, controlling plans, and leading projects as assigned.
  
• Must ensure adherence to FDA and ISO requirements throughout the product life cycle.
  
• Develop and execute verification and validation plans and protocols associated with product/process quality according to FDA and ISO requirements.
  
• Ability to manage multiple projects simultaneously without supervision. This includes creating detailed and accurate project tasks and schedules, interfacing with project team members and support personnel, and solving project-related conflicts and issues.
  
• Strong working knowledge of design and process controls.
  
• Travel when required to support business projects as a validation representative.
  
• Knowledge of process and product risk assessments.
  

• Knowledge of global regulatory and quality requirements associated with medical devices.
  
• Working knowledge of ISO 13485 and 21 CFR Part 820.
  
• Experience with formal problem solving in a team environment.