Validation Specialist

Katalyst HealthCares and Life Sciences

• $80K — $95K *
Nashua, NH 03060In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Life Sciences, or related discipline required.
  • 5+ years of hands-on validation experience with GMP equipment and utilities.
  • Strong understanding of cGMP, GDP, and SOP requirements.
  • Familiarity with temperature mapping and controlled temperature units.
  • Experience in executing IQ/OQ/PQ protocols.

Responsibilities

  • Support cleaning validation activities and documentation.
  • Perform temperature mapping and requalification of controlled temperature units.
  • Execute IQ/OQ/PQ, requalification, and periodic reviews for equipment.
  • Assist with the commissioning and qualification of new equipment.
  • Generate validation documentation to meet regulatory standards.
  • Participate in audit readiness and support for regulatory inspections.

Benefits

  • Opportunity to work in a GMP-regulated environment.
  • Exposure to advanced engineering and validation processes.
  • Collaboration with cross-functional teams including Engineering and Operations.
  • Development of expertise in regulatory compliance and validation standards.
Full Job Description
Requirements:
  • Support cleaning validation activities, protocol execution, sampling, and documentation.
  • Perform temperature mapping and requalification of controlled temperature units.
  • Execute IQ/OQ/PQ, requalification, and periodic review for GMP equipment and utilities.
  • Support commissioning, installation, and qualification of new or modified equipment.
  • ssist with equipment troubleshooting alongside Engineering and Operations.
  • Generate validation documentation following cGMP, GDP, and SOP requirements.
  • Support validation lifecycle activities, change controls, investigations, and CAPAs.
  • Participate in audit readiness and regulatory inspection support.
  • Bachelor's degree in Engineering, Life Sciences, or related discipline required.
  • 5+ years of hands-on validation experience with GMP equipment and utilities.
* Ladders Estimates

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