Senior Validation Specialist - Pharma/Medical Devices

Integration International Inc.; Marion (NC); On-site; USD 61,992 - 78,523; Full time

Job summary

Integration International Inc. is seeking a Validation Specialist to support pharmaceutical and medical device operations in Marion, North Carolina. In this role, you will execute validation deliverables and ensure compliance with FDA and ISO regulations while collaborating with various teams in a controlled GMP manufacturing environment.

The ideal candidate will have experience in medical device manufacturing, hands-on experience with validation activities, and proficiency in using Kneat Gx for electronic validation management.

Qualifications

• Experience supporting medical device manufacturing under ISO 13485.
• Experience with automation and controls.
• Exposure to validation remediation or regulatory commitment work.

Responsibilities

• Execute validation activities to support manufacturing systems.
• Maintain compliance with FDA and ISO regulations.
• Collaborate with cross-functional teams providing on-site support.

Skills

Detail oriented with a strong compliance mindset

Strong problem solving skills

Effective communication with cross functional teams

Tools

Kneat Gx

PLC/SCADA

MES

Job description

Integration International Inc. is seeking a Validation Specialist to support pharmaceutical and medical device operations in Marion, North Carolina. In this role, you will execute validation deliverables and ensure compliance with FDA and ISO regulations while collaborating with various teams in a controlled GMP manufacturing environment.

The ideal candidate will have experience in medical device manufacturing, hands-on experience with validation activities, and proficiency in using Kneat Gx for electronic validation management.