Demo

Validation Specialist

Tailored Management
Portsmouth, NH Full Time
POSTED ON 2/27/2025
AVAILABLE BEFORE 5/23/2025

Job Title : Equipment Validation Specialist

Location : 101 International Drive, Portsmouth, NH 03801

Job Type : 9-Month Contract with Possibility of Extension or Full-Time Conversion

Work Schedule : Full-time, 5 days a week, 8 : 00 AM to 5 : 00 PM (Onsite)

Work Environment : 100% Onsite.

Department : Quality Control

Reports to : Associate Director, QC

Job Description :

The Equipment Validation Specialist will be responsible for conducting temperature mapping studies, reviewing and approving validation protocols, and supporting qualification activities for temperature-controlled equipment such as chambers, incubators, and freezers. The role involves integrating these systems with data historians and ensuring compliance with regulatory requirements.

Key Responsibilities :

  • Conduct temperature mapping for chambers, incubators, freezers, and other temperature-controlled equipment.
  • Review and approve validation protocols and temperature mapping studies.
  • Support the qualification of new equipment and ensure compliance with industry regulations.
  • Integrate systems with data historians and ensure proper data collection.
  • Utilize K Validator software for validation and mapping studies.
  • Adhere to regulatory requirements and follow URS (User Requirements Specifications).
  • Ensure validation documentation is complete and meets industry standards.
  • Work within established budget and project timelines.
  • Follow company validation strategies and best practices.

Education and Experience :

  • Bachelor’s degree in a science-related field required.
  • 5-8 years in equipment validation and temperature mapping
  • Proficiency with K Validator and temperature mapping studies.
  • Familiarity with regulatory compliance and URS requirements.
  • Strong understanding of equipment integration with data historians.
  • Experience working with validation strategies and protocol documentation.
  • Strong attention to detail and organizational skills.
  • Must-Have Skills :

  • Temperature mapping experience.
  • Expertise with K Validator software.
  • Experience conducting and reviewing validation protocols.
  • Understanding of equipment integration with data historians.
  • Compliance knowledge regarding regulatory requirements.
  • Ability to work independently and ensure timely project completion.
  • Work Environment :

  • Work with laboratory and production equipment in a regulated environment.
  • Collaboration with cross-functional teams, including validation engineers and quality assurance teams.
  • Application Process :

  • Interested candidates should submit their resumes highlighting relevant experience and skills in quality control, validation, and analytical equipment management.
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