Onsite Validation Specialist - IQ/OQ/PQ for Pharma QC

Radiant Systems Inc; Thousand Oaks (CA); Sur place; USD 69 000 - 74 000; Temps partiel

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Attention to detail

Communication skills

Problem-solving

Technical writing

Microsoft Word/Excel/Outlook

Formation

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

Outils

Kneat IOQ

Document management systems

Description du poste

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.