Lead Validation Specialist — cGMP IQ/OQ/PQ Expert (Onsite)

Lancesoft; Thousand Oaks (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Lancesoft seeks a Validation Specialist to support qualification of environmental monitoring instruments used in cGMP manufacturing suites. You will author, execute, and close validation documentation, develop procedures, and coordinate with Quality, Manufacturing, QC and IT.

The role requires hands-on IQ/OQ/IOQ protocol work, strong technical writing, and ability to manage deliverables in a regulated environment. Onsite in Thousand Oaks, CA.

Qualifications

• Minimum 3 years in validation, equipment qualification, QC, engineering, QA, or technical ops in a regulated environment.
• Experience writing and executing IQ, OQ, and IOQ protocols.
• Strong technical writing skills (protocols, reports, SOPs).
• Working knowledge of cGMP and 21 CFR requirements.
• Familiarity with Kneat and electronic quality systems is a plus.
• Independently manage deliverables, priorities, and timelines.
• Collaborate with cross-functional quality and manufacturing teams.

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 IOQ 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.
• Document, investigate, and support closure of protocol discrepancies.
• Work cross-functionally with Quality Control, Quality Assurance, Manufacturing, and IT.
• Ensure qualification records are complete and inspection-ready in the document system.
• Track milestones, communicate status, and drive timely deliverables.

Skills

IQ/OQ/IOQ

cGMP knowledge

Documentation

Kneat experience

Project management

Cross-functional teamwork

MS Word/Excel/Outlook

Technical writing

Education

Bachelor's degree in Engineering/ Chemistry/ Biology/ Microbiology/ Biotechnology/ Pharmaceutical Sciences

Tools

Kneat

Document management systems

Electronic quality systems

Job description

Lancesoft seeks a Validation Specialist to support qualification of environmental monitoring instruments used in cGMP manufacturing suites. You will author, execute, and close validation documentation, develop procedures, and coordinate with Quality, Manufacturing, QC and IT.

The role requires hands-on IQ/OQ/IOQ protocol work, strong technical writing, and ability to manage deliverables in a regulated environment. Onsite in Thousand Oaks, CA.