Validation Specialist

Katalyst HealthCares and Life Sciences

• $70K — $95K *
Framingham, MA 01702In-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 a related discipline required.
  • 5+ years of hands-on validation experience with GMP equipment and utilities.
  • Strong understanding of cGMP, GDP, and SOP compliance requirements.
  • Experience with commissioning and qualification processes for bio/pharma equipment.
  • Proficient in generating validation documentation and reports.],
  • responsibilities
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  • Perform cleaning validation activities, protocol execution, and documentation.
  • Execute temperature mapping and requalification of controlled temperature units.
  • Conduct IQ/OQ/PQ, requalification, and periodic reviews of GMP equipment and utilities.
  • Assist in the commissioning and qualification of new or modified equipment.
  • Collaborate with Engineering and Operations for equipment troubleshooting.
  • Generate validation documentation adhering to industry standards.
  • Participate in audit readiness and support during regulatory inspections.

Responsibilities

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Full Job Description
Summary :
  • 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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