Validation Specialist
Indexed description
Required Qualifications
The Validation Specialist (Contract) will support pharmaceutical and medical device operations by executing and maintaining compliant validation activities using Kneat Gx as the electronic validation lifecycle management system
This role is focused on hands on execution of validation deliverables to support equipment, process, utility, and computerized system readiness in accordance with FDA, ISO, and cGMP requirements
The specialist will work closely with Engineering, Quality, Automation, IT, and Operations to ensure systems and equipment are validated, audit ready, and capable of supporting safe, compliant production
Validation Execution (Primary Role)
Execute IQ, OQ, PQ, requalification, and validation maintenance activities for pharma and medical device manufacturing systems.
Manufacturing and packaging equipment
Utilities (compressed air, clean utilities, environmental controls)
Computerized systems (automation, data acquisition, MES, LIMS, vision systems)
Apply risk-based validation methodologies aligned with GAMP 5 and industry best practices.
Preferred Qualifications
Experience supporting medical device manufacturing under ISO 13485.
Experience with automation and controls (PLC/SCADA), vision systems, or MES.
Experience supporting high speed packaging or assembly lines.
Exposure to validation remediation or regulatory commitment work
Required Technical Skills
KNEAT Gx Lifecycle Management
Author, execute, review, and route validation documents within KNEAT Gx.
Maintain End To End Traceability Between
User Requirements (URS)
Risk Assessments
Test cases and protocols
Deviations and final reports
Ensure proper use of KNEAT Gx workflows, execution controls, and electronic approvals.
Maintain compliance with 21 CFR Part 11 and data integrity expectations.
Deviation, Change Control & CAPA Support
Document and investigate validation deviations within KNEAT Gx
Support change control impact assessments affecting validated systems
Participate in root cause analysis and CAPA implementation when required
Regulatory & Quality Compliance
Ensure Validation Deliverables Comply With
oFDA cGMP regulations (21 CFR Parts 210/211, Part 11)
ISO 13485 (Medical Devices)
Internal Quality Management System (QMS) requirements
Support regulatory inspections and customer audits by providing validation documentation and responses.
Maintain validation documentation in a state of continuous inspection readiness
Responsibilities
Collaborate with Engineering, Quality, IT, Automation, Manufacturing, and external vendors.
Provide on floor support during commissioning, troubleshooting, and validation execution.
Support site initiatives such as new equipment introduction, line upgrades, remediation efforts, and capacity expansions.
Detail oriented with a strong compliance mindset
Ability to work independently under contract deliverables
Strong problem solving and root cause analysis skills
Effective communication with cross functional teams
Comfortable working in production and controlled environments
On site support in a controlled GMP manufacturing environment
May require off shift or weekend support during execution windows
PPE and gowning requirements may apply depending on area
Additional Details
Industry: Pharmaceutical & Medical Devices
Contract Type: Contract (On site / Hybrid, as required)
Duration: Contract basis (length defined by project needs)
On site support in a controlled GMP manufacturing environment
May require off shift or weekend support during execution windows
PPE and gowning requirements may apply depending on area
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