Validation Specialist

ProKatchers LLC; Thousand Oaks (CA); On-site; USD 85,000 - 110,000; Full time

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

• writing and/or executing qualification protocols
• validation
• IQ/OQ/PQ

Job Description:

• Lead qualification activities for Climet environmental monitoring instruments, including developing qualification plans, risk assessments, and timelines.
• Author and execute IQ/OQ/PQ or IOQ protocols, prepare summary reports, and ensure complete qualification closeout documentation.
• Draft and maintain SOPs, work instructions, forms, and other GMP-controlled documents while investigating and resolving discrepancies.
• Coordinate with vendors, QC, QA, Manufacturing, and IT for installation, calibration, maintenance, and qualification activities.
• Ensure inspection-ready records and timely project completion while maintaining compliance with cGMP, GDP, 21 CFR, and site procedures.