Validation Specialist

Stefanini Group is hiring!

Stefanini is looking for Validation Specialist in Marion NC (Hybrid)

For quick Apply please reach out to Rachit Rastogi - call: / email:

Work Hours:M-F (40 hours)

Work Location:Marion NC (Hybrid)

Shift:1st Shift

• 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)

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.
  
  

Listed salary ranges may vary based on experience qualifications and local market. Also some positions may include bonuses or other incentives.

Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.

About Stefanini Group

The Stefanini Group is a global provider of offshore onshore and near shore outsourcing IT digital consulting systems integration application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas Europe Africa and Asia and more than four hundred clients across a broad spectrum of markets including financial services manufacturing telecommunications chemical services technology public sector and utilities. Stefanini is a CMM level 5 IT consulting company with a global presence. We are CMM Level 5 company.

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