Lead Validation Engineer - IQ/OQ/PQ for Environmental Monitoring

ProKatchers LLC

Thousand Oaks (CA)

On-site

USD 85,000 - 110,000

Full time

46 hours ago
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Job summary

ProKatchers LLC in Thousand Oaks seeks a qualified professional to lead qualification activities for Climet environmental monitoring instruments. You will develop qualification plans, assess risks, and manage timelines to ensure project milestones are met.

You will author and execute IQ/OQ/PQ/IOQ protocols, prepare summary reports, and maintain complete qualification closeout documentation. The role requires drafting GMP-controlled documents and coordinating with multiple departments to stay

Qualifications

  • Experience drafting and executing qualification protocols.
  • Familiarity with GMP, GDP, 21 CFR.
  • Ability to coordinate with multiple departments.

Responsibilities

  • Lead qualification activities for environmental monitoring instruments.
  • Author and execute IQ/OQ/PQ or IOQ protocols and prepare closeout documentation.
  • Draft and maintain SOPs and work instructions while addressing discrepancies.
  • Coordinate with vendors, QC, QA, Manufacturing, and IT for installations and calibrations.
  • Ensure inspection-ready records and timely project completion.

Skills

Qualification protocols
IQ/OQ/PQ execution
GxP compliance

Job description

ProKatchers LLC in Thousand Oaks seeks a qualified professional to lead qualification activities for Climet environmental monitoring instruments. You will develop qualification plans, assess risks, and manage timelines to ensure project milestones are met.

You will author and execute IQ/OQ/PQ/IOQ protocols, prepare summary reports, and maintain complete qualification closeout documentation. The role requires drafting GMP-controlled documents and coordinating with multiple departments to stay

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