Validation Specialist

Job Title: Validation Specialist (Hybrid role)

Location: Marion, NC 28752

Duration: 12+ months (Possible extension)

Timing: 1st shift (Monday to Friday)

Pay rate: $50-55/- hourly on W2

Job Description:

• The Validation Specialist 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.

Responsibilities:

• Validation Execution (Primary Role)
• Execute IQ, OQ, PQ, requalification, and validation maintenance activities for pharma and medical device manufacturing systems.
• Support validation of:
• 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.

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.

Cross Functional Support:

• 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.

Job Requirements:

Core Competencies:

• 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.

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.

Work Conditions:

• 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.

Best regards,

Rachit Rastogi (Rick)

Senior Talent Acquisition Specilaist

LinkedIn: linkedin.com/in/rachit-rastogi-a6497827

Email: View email address on click.appcast.io