Validation Specialist

Accord Technologies Inc; Marion (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Accord Technologies Inc in Marion, NC is seeking a Validation Specialist (Contract) to execute and maintain compliant validation activities for pharmaceutical and medical device systems using Kneat Gx, ensuring 21 CFR Part 11 compliance and end-to-end traceability.

You will collaborate with Engineering, Quality, Automation and IT to validate equipment, utilities, and computerized systems, perform IQ/OQ/PQ, and support deviations, CAPA, and regulatory inspections in a GMP environment on site.

Qualifications

• Hands-on validation execution for pharma and medical device systems.
• Maintain compliant validation activities aligned with FDA, ISO, and cGMP requirements.
• Work with cross-functional teams to ensure audit readiness and validated state.

Responsibilities

• Execute IQ, OQ, PQ, requalification, and validation maintenance for pharma/medical devices.
• Validate equipment, utilities, and computerized systems (MES, LIMS, vision).
• Maintain end-to-end traceability from URS to final reports and deviations.

Skills

Documentation

Collaboration

Problem solving

Attention to detail

Tools

KNEAT Gx Lifecycle Management

Job description

W2 contract

Must have experience supporting

Marion, NC, USA

12 months

W2 contract

Must have experience supporting medical device manufacturing under ISO 13485. Writing test protocols within KNEAT Gx Knowledge of CQV (Commissioning Qualification and Validation) process.

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 FDA 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