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Engineer III, Validation
Company: Thermo Fisher Scientific
Location: Grand Island, NY
Employment Type: Full Time
Date Posted: 10/15/2021
Expire Date: 01/02/2022
Job Categories: Biotechnology and Pharmaceutical, Computers, Software, Engineering, Healthcare, Practitioner and Technician, Information Technology, Quality Control, Research & Development, Medical, Writing/Authoring
Job Description
Engineer III, Validation

Key Objectives of the role:

  • Develops all written plans related to the validation and re-validation of equipment, processes, packaging and/or systems used in the manufacture and testing of regulated products.
  • Evaluates the potential risks and finds mitigation through sampling and testing identified by Design of Experiment.
  • Executes assignments of diverse scope and complexity according to the plan and records all activities in a defendable manner.
  • Solves problems in complicated situations using analytical and creative thinking skills.
  • Provides validation subject matter expertise to other team members.
  • Supports complex, cross-functional quality investigations in a variety of areas (e.g. electrical, mechanical, chemistry and computer systems/software) to determine root cause and corrective action.
  • Conducts advanced data analyses to determine quality problems and to identify larger scale quality improvements.
  • Participates in cross functional team projects (R&D, Mfg, Vendors, etc). Examples: support new product introduction projects or quality improvement projects.

Minimum Qualifications (must have):

  • Bachelor’s degree in Engineering or Science Discipline.
  • 5 years of experience within the Medical Device or Pharmaceutical Industry supporting the manufacture of Regulated Products
  • 2 years of experience with computer system and control system validation experience

Knowledge of:

  • Validation in a FDA Regulated Environment
  • Quality standards (e.g., 21 CFR Part 820, ISO 13485, Part 11)
  • Quality tools (e.g. FMEA, Risk Analysis, Root Cause Analysis, DOE)
  • Computer Systems (e.g. TrackWise, AGILE, E1/SAP)

Proficient in:

  • Computer applications and current software (Microsoft Excel, Outlook, Word, Access, Project)
  • Technical writing
  • Improving upon already established validated systems
Contact Information
Company Name: Thermo Fisher Scientific
Website: https://thermofisher.contacthr.com/...
Company Description:

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