Validation Specialist

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

Actual Job Tilte - Validation Specialist 5 days a week Onsite.

Summary The Validation Specialist will support qualification of Climet environmental monitoringninstruments used in cGMP manufacturing suites. This role will author, execute, and closenvalidation 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 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

• 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.
• 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, organization, communication, and problem-solving skills.
• Proficiency with Microsoft Word, Excel, and Outlook.
• Experience with environmental monitoring systems, airborne particle counters, Climet instruments, cleanrooms, or QC Microbiology is preferred.
• 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.

Physical Demand

Ability to perform desk-based documentation work and work in laboratory, manufacturing, and controlled-area environments. Ability to stand and walk for extended periods during protocol execution and field activities. Ability to occasionally bend, reach, stoop, push, pull, and move supplies or equipment. Ability to occasionally lift and carry up to approximately 25 pounds. Ability to wear required personal protective equipment and cleanroom gowning.

Working Environment

Work is performed in office, laboratory, and cGMP manufacturing environments. Entry into controlled areas and cleanrooms may be required;special gowning and protective equipment may be required. May work around common laboratory or manufacturing materials, including cleaning agents, alcohols, and buffers. Project timelines and manufacturing schedules may require schedule flexibility, including occasional off-shift or weekend support.