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11 days ago
Simply Recruitment Partner
Salary band: $10k - $15k
Location: North America, United States, Wisconsin
Job type: Permanent
Contact: PSC Biotech Corp.
Category: Engineer
Job Description

PSC Biotech Corporation is looking for Equipment Validation/Qualification Engineers with minimum 2 years of experience in qualification and validation of equipment systems typically found in cGMP Bio-pharmaceutical facilities. Our client is located in Madison WI Area.

Responsibilities

  • Candidate must have experience in validation of refrigerators, freezers, centrifuges, thermal cyclers, and other benchtop lab equipment.
  • Candidate must have experience in equipment validation including execution, analysis, and reporting.
  • Coordinate with cross functional resources in the execution of validation projects and ensure compliance with FDA, cGMP and other appropriate regulations, as required.
  • Create, execute validation protocols and write validation summary reports.
  • Excellent writing skills to prepare IOQ.
  • Must have experience in a pharmaceutical setting providing equipment qualification and process validation services.
  • Experience using Kaye validator is strongly preferred.



Requirements

Experience working in FDA regulated environment is preferred.
Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ,OQ,PQ, RTM, summary report).
Excellent communication skills.
Ability to work as a team player in a consulting environment.
Proficiency with MS Office tools.
Documentation management.

Company Description
PSC Biotech Corporation is a global, employee owned, life sciences consultancy that performs projects and staff augmentation in the following disciplines: Engineering, Information Technology, Technical Services, Validation, Compliance, Regulatory Submissions, Clinical, Project Management and Quality Assurance. PSC Biotech, incorporated in 1996, has been performing projects globally for over 15 years.

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