Validation Specialist

Radiant Systems Inc; Thousand Oaks (CA); On-site; USD 69,000 - 74,000; Part time

Job summary

Major Pharmaceutical Client in Thousand Oaks, CA is seeking a Validation Specialist to support qualification of Climet environmental monitoring instruments used in cGMP manufacturing.

You will author, execute, and close validation documentation, develop procedures, and coordinate activities with Quality, Manufacturing, and other stakeholders. The role requires independent management of qualification deliverables in compliance with site procedures and regulatory requirements.

Qualifications

• Strong technical writing skills including protocols and reports.
• Experience with qualifying equipment or systems in regulated environments.
• Proficiency with Microsoft Word, Excel, and Outlook.
• Familiarity with cGMP and 21 CFR.
• Experience with environmental monitoring systems is a plus.

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 closeout documentation.
• Coordinate instrument installation, calibration, and maintenance activities.

Skills

Attention to detail

Communication skills

Problem-solving

Technical writing

Microsoft Word/Excel/Outlook

Education

Bachelor's degree in Engineering, Chemistry, Biology, Microbiology, Biotechnology, Pharmaceutical Sciences, or related field

Tools

Kneat IOQ

Document management systems

Job description

Client: Major Pharmaceutical Client

Position: Validation Specialist

Duration: 3+ months on W2

Location: Thousand Oaks, CA 91320

Pay Rate: $50.00-$54.00/ Hr on W2

Job Description

Work Schedule:

5 days a week onsite

Department/Location:

Quality Control (QC) - Thousand Oaks

Summary

• The Validation Specialist will support the 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.
• The individual will independently manage qualification deliverables while ensuring compliance with site procedures and applicable regulatory requirements.

Essential Duties and 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 the 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 the timely completion of deliverables.

Qualifications

• 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 discrepancy documentation.
• Working knowledge of cGMP, Good Documentation Practices, and applicable regulatory requirements, including 21 CFR.
• Familiarity with document management systems and electronic quality systems. Experience executing IOQs through Kneat is a plus.
• Ability to independently manage project deliverables, priorities, timelines, and follow-up actions.
• Ability to work effectively with cross-functional technical and quality teams.
• Strong attention to detail, organizational, communication, and problem-solving skills.
• Proficiency in Microsoft Word, Excel, and Outlook.
• Experience with environmental monitoring systems, airborne particle counters, Climet instruments, cleanrooms, or QC Microbiology is preferred.

Education and/or Experience

• 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.
• Equivalent combinations of education, training, and directly relevant experience may be considered.