Senior Validation Specialist

7 days ago

Middletown, Virginia, United States Thermo Fisher Scientific Full time
Job Description

As a key member of the Thermo Fisher Scientific team, you will play a critical role in supporting the validation of our products and processes. This includes automation equipment, product transfers, new product development, and working as part of a cross-functional team responsible for sustaining change.

Key Responsibilities
  • Assist the validation team in supporting all site validation activities, ensuring compliance with quality and manufacturing requirements.
  • 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, ensuring alignment with regulatory requirements.
  • Support development projects, transfer projects, process changes, and engineering projects, providing guidance on quality standards, inspection techniques, and frequencies.
  • Direct and oversee validation activities for Operations, Engineering, Quality Assurance, and other functional areas, ensuring adherence to FDA and ISO requirements.
  • Review, revise, and maintain site validation procedures, qualification protocols, and associated data, ensuring compliance with regulatory requirements.
  • Lead and/or assist in training of staff involved in validation activities, ensuring knowledge transfer and skill development.
  • Assist Quality, Operations, and Engineering personnel during inspections or audits, ensuring preparedness and compliance.
  • Perform other duties as assigned by Staff Validation Engineer and direct manager, ensuring alignment with business objectives.
Requirements
  • Bachelor's degree from a four-year college or university and 5+ years of relevant experience in the pharmaceutical, medical device, or in-vitro diagnostics industry, or an Associate degree and 8+ years of relevant experience.
  • Knowledge of global regulatory and quality requirements associated with medical devices, including ISO 13485 and 21 CFR Part 820.
  • Proficient in Microsoft Office Suite and experience with formal problem-solving in a team environment.
  • Detail-oriented with the ability to lead multiple projects and activities as assigned, ensuring timely completion and quality results.
  • Strong working knowledge of design and process controls, as well as experience with statistical analysis and process control.
  • Ability to influence and coordinate activities of personnel over which he/she has no direct authority, ensuring effective communication and collaboration.
  • Independent self-starter who is capable of planning schedules, controlling plans, and leading projects as assigned, ensuring alignment with business objectives.
  • Must ensure adherence to FDA and ISO requirements throughout the product life cycle, ensuring compliance and quality results.
Preferred Qualifications
  • Experience with various software platforms, such as Minitab, Blue Mountain RAM, and Master Control.
  • Knowledge of process and product risk assessments, as well as experience with formal problem-solving in a team environment.
  • Ability to manage multiple projects simultaneously without supervision, ensuring timely completion and quality results.
  • Strong working knowledge of global regulatory and quality requirements associated with medical devices, including ISO 13485 and 21 CFR Part 820.
Physical Requirements
  • Normal office and manufacturing environment, with occasional travel required to support business projects as a validation representative.
  • Position may require frequent communication and walking to other areas, with designated PPE required as needed.
  • Position will require sitting and standing, with occasional lifting and/or moving up to 25 pounds.

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