Validation Specialist

Katalyst HealthCares and Life Sciences

• $70K — $95K *
US-AnywhereRemote in Framingham, MA
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
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.
  • Experience with validation documentation generation.
  • Knowledge of temperature mapping and controlled temperature units.

Responsibilities

  • Support cleaning validation activities and protocol execution.
  • Perform temperature mapping and requalification of controlled temperature units.
  • Execute IQ/OQ/PQ for GMP equipment and utilities.
  • Assist in commissioning and qualification of new or modified equipment.
  • Generate validation documentation in compliance with regulatory requirements.
  • Support validation lifecycle activities and change control processes.
  • Participate in audit readiness and regulatory inspection support.

Benefits

  • Collaborative work environment with cross-departmental interaction.
  • Opportunities for professional development and training.
  • Exposure to a variety of equipment and technologies.
  • Involvement in regulatory inspections and compliance activities.
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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