Validation Analyst

• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of equipment.
• Drive/own the validation plans and execution of equipment changes and process improvements.
• Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
• Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated state.
• Program, organize, and maintain Validation equipment and supplies including dataloggers and probes.
• Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ), Clean-In-Place (CIP), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment.
• Develop validation protocols from plans and engineering documents.
• Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc.
• Perform assigned Quality Systems activities within Document Management System (DMS), TrackWise Quality System (Change Control, Deviation, CAPA)
• Perform other duties as assigned.

Copilot said:

• Job Description
• Equipment Validation Analyst
• Position Summary
• The Equipment Validation Analyst is responsible for the execution, maintenance, and continuous improvement of equipment validation and cleaning validation programs within a GMP-regulated biopharmaceutical manufacturing environment. This role supports the qualification of manufacturing, laboratory, storage, and utility equipment while ensuring systems remain in a validated state throughout their lifecycle.
• The position will focus heavily on equipment requalification activities, validation lifecycle management within Kneat, protocol generation and execution, and support of cleaning validation activities including CIP, COP, SIP, media hold, and media fill programs. The Equipment Validation Analyst will collaborate closely with Manufacturing, Quality, Engineering, and Quality Control teams to support operational readiness, compliance, and continuous improvement initiatives.
• Key Responsibilities
• Equipment Validation & Qualification
• Execute equipment validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and support the development of Performance Qualification (PQ) protocols and reports.
• Develop, author, review, and execute validation protocols and reports using Kneat.
• Build, maintain, and manage equipment requalification programs and schedules within Kneat.
• Perform validation lifecycle management activities to ensure GMP equipment remains in a validated state.
• Support qualification of manufacturing, laboratory, utility, and storage equipment across the facility.
• Drive validation plans and execution for equipment modifications, upgrades, and process improvements.
• Cleaning Validation
• Support cleaning validation activities for GMP manufacturing systems including:
• Clean-In-Place (CIP)
• Clean-Out-of-Place (COP)
• Steam-In-Place (SIP)
• Media Hold Studies
• Media Fill Studies
• Draft and maintain cleaning validation SOPs, protocols, reports, and associated documentation.
• Support cleaning validation strategy development for both single-use and reusable process equipment.
• Execute cleaning validation studies and analyze results to ensure compliance with regulatory and site requirements.
• Specialized Equipment Qualification
• Support qualification and requalification of:
• Autoclaves
• Parts Washers
• Controlled Temperature Storage Units
• Ambient and Cold Storage Areas
• Laboratory Equipment
• Clean Utilities
• Shipping and Transportation Systems
• Support temperature mapping studies and thermal validation activities.
• Utilize validation data acquisition systems and temperature mapping equipment, including dataloggers and probes.
• Experience with Ellab thermal validation systems is highly desirable.
• Validation Systems & Quality Compliance
• Utilize Kneat as the primary validation lifecycle management platform for protocol development, execution, approval, and documentation management.
• Program, organize, calibrate, and maintain validation equipment including thermocouples, probes, and datalogging devices.
• Support Validation Maintenance quality systems reviews and periodic requalification activities.
• Ensure all validation activities are conducted in accordance with GMP, GDP, and company procedures.
• Maintain validation documentation in an audit-ready state.
• Quality Systems Support
• Support Change Controls, Deviations, CAPAs, Risk Assessments, and Investigations related to validation activities.
• Perform assigned activities within electronic quality systems such as:
• TrackWise
• Document Management Systems (DMS)
• Change Control Systems
• CAPA Programs
• Deviation Management Systems
• Review and provide technical input on SOPs, validation protocols, reports, and quality documentation.
• Participate in internal audits and regulatory inspections as a Validation SME when required.
• Technical Support & Collaboration
• Provide technical and validation SME support to Manufacturing, Quality Control, Engineering, Quality Assurance, and Operations teams.
• Support troubleshooting and root cause investigations involving validated equipment and systems.
• Collaborate in cross-functional project teams supporting facility and process improvements.
• Ensure validation deliverables support business objectives, compliance requirements, and operational needs.
• Required Qualifications
• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related technical discipline.
• 3+ years of equipment validation experience within the pharmaceutical, biotechnology, medical device, or regulated manufacturing industry.
• Hands-on experience with Kneat Validation software is required.
• Experience executing IQ/OQ protocols and supporting PQ activities.
• Experience supporting equipment lifecycle management and requalification programs.
• Knowledge of GMP, GDP, and validation lifecycle requirements.
• Strong technical writing and documentation skills.
• Experience supporting investigations, deviations, CAPAs, and change controls.
• Preferred Qualifications
• Experience with Cleaning Validation programs including CIP, COP, SIP, Media Hold, and Media Fill studies.
• Experience with temperature mapping and thermal validation.
• Experience using Ellab validation systems and software.
• Knowledge of autoclave qualification and thermal process validation.
• Experience with TrackWise and electronic quality management systems.
• Experience working in biologics, cell therapy, gene therapy, vaccine, or sterile manufacturing environments.
• Familiarity with single-use manufacturing systems.
• Key Skills & Competencies
• Equipment Validation
• Cleaning Validation
• Kneat Validation Software (Required)
• IQ/OQ/PQ Execution
• Requalification Program Management
• CIP/COP/SIP Validation
• Temperature Mapping
• Thermal Validation
• Autoclave Qualification
• GMP Compliance
• Technical Writing
• Quality Systems (TrackWise, DMS)
• Deviation and CAPA Management
• Cross-Functional Collaboration
• Problem Solving and Root Cause Analysis
• Preferred Candidate Profile
• The ideal candidate will have strong hands-on experience with Kneat, equipment lifecycle validation, and GMP documentation management. Candidates with experience in cleaning validation, media hold studies, autoclave qualification, temperature mapping, and equipment requalification programs within a biopharmaceutical manufacturing environment will be highly preferred. Experience supporting single-use manufacturing operations and utilizing Ellab thermal validation systems is a strong plus.