Validation Specialist

Virtual Company; 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

We are a national staffing firm and are currently seeking a Validation Specialist for a prominent client of ours. This position is located in Thousand Oaks, CA 91320. Details of the position are as follows:

Job Details

• Pay: $54.60-56.49 based on experience.


• 3-month assignment, possibility for conversion/extension based on performance and business needs.


• Monday - Friday: 1st Shift(Onsite)


• Position will be mainly responsible for support qualification of Climet environmental monitoring instruments used in cGMP manufacturing suites. This role will author, execute, and close validation documentation; develop associated procedures; and coordinate activities with Quality, Manufacturing, Quality Control and other stakeholders.
  
  
  
  • Key Responsibilities:
  
  
  
  
  • Lead qualification activities for Climet environmental monitoring instruments and related components.
  
  
  • 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, vendor support, calibration, and maintenance activities as applicable.
  
  
  • Document, investigate, and support closure of protocol discrepancies, and exceptions.
  
  
  • Work cross-functionally with Quality Control, Quality Assurance, Manufacturing, and Information Technology.
  
  
  • Ensure qualification records are complete, accurate, inspection-ready, and maintained in the site document management system.
  
  
  • Track project milestones, communicate status, identify risks, and drive timely completion of deliverables.
  
  
  
  
  
  

Qualifications

• Bachelor’s degree in engineering, Chemistry, Biology, Microbiology, Biotechnology, Pharmaceutical Sciences, or a related technical field preferred.


• Minimum of 3 years of relevant validation, equipment qualification, Quality Control, Engineering, Quality Assurance, or technical operations experience in a regulated manufacturing environment.


• Minimum of 2 years of direct experience writing and/or executing qualification protocols and preparing associated controlled documentation preferred.


• Experience qualifying equipment, instruments, or systems in a pharmaceutical, biotechnology, medical device, or similarly regulated environment.


• Hands-on experience authoring and executing IQ, OQ, and/or IOQ protocols.


• Strong technical writing skills, including protocols, reports, SOPs, and discrepancies.


• Working knowledge of cGMP, Good Documentation Practices, and applicable regulatory requirements, including 21 CFR.


• Familiarity with document management systems and electronic quality systems, experience with execution of IOQs through Kneat a plus.


• Experience with environmental monitoring systems, airborne particle counters, Climet instruments, cleanrooms, or QC Microbiology is preferred.