Validation Analyst in Kittery Point, Maine

Equipment Validation Analyst

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.

• 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.

• 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.

• 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 data loggers and probes.
• Experience with Ellab thermal validation systems is highly desirable.

• 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 data logging 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.

• Support Change Controls, Deviations, CAPAs, Risk Assessments, and Investigations related to validation activities.
• Perform assigned activities within electronic quality systems such as:
• Track Wise
• 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.

• 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.

• Bachelor's…