Environmental Monitoring Validation Lead

The Fountain Group; Thousand Oaks (CA); On-site; USD 75,000 - 78,000; Full time

Job summary

The Fountain Group in Thousand Oaks, CA is seeking a Validation Specialist for a 3-month on-site assignment. The role focuses on qualification of Climet environmental monitoring instruments used in cGMP manufacturing, with IQ/OQ/PQ execution and close coordination with Quality, Manufacturing, QA and IT.

Ideal candidates hold a bachelor’s degree in a technical field and have 3+ years’ experience in validation or equipment qualification in a regulated environment; strong technical writing and

Qualifications

• Bachelor’s degree in a technical field is preferred.
• Minimum of 3 years in validation, equipment qualification, or QA in regulated manufacturing.
• Experience writing and executing qualification protocols and documentation.
• Experience with IQ/OQ/PQ for equipment or systems.
• Knowledge of cGMP, GDP, and 21 CFR regulations.
• Familiarity with document management systems and electronic QA systems.

Responsibilities

• Lead qualification activities for Climet environmental monitoring instruments.
• Develop qualification plans, risk assessments, and project timelines.
• Author, review, and execute IQ, OQ and PQ protocols.
• Prepare qualification summary reports and final closeout documentation.
• Draft and revise SOPs, work instructions, forms, and other controlled documents.
• Coordinate instrument installation, calibration, and maintenance.
• Document, investigate, and support closure of protocol discrepancies.
• Work cross-functionally with Quality, Manufacturing, QA, and IT.
• Ensure qualification records are complete and inspection-ready.
• Track milestones, communicate status, and drive timely deliverables.

Skills

Technical writing

Project coordination

Cross-functional teamwork

Education

Bachelor’s degree in engineering, chemistry, biology, microbiology, biotechnology, pharmaceutical sciences, or related technical field

Tools

Kneat

Job description

The Fountain Group in Thousand Oaks, CA is seeking a Validation Specialist for a 3-month on-site assignment. The role focuses on qualification of Climet environmental monitoring instruments used in cGMP manufacturing, with IQ/OQ/PQ execution and close coordination with Quality, Manufacturing, QA and IT.

Ideal candidates hold a bachelor’s degree in a technical field and have 3+ years’ experience in validation or equipment qualification in a regulated environment; strong technical writing and