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Lead Validation Specialist

Clayton, North Carolina

Piper Companies Logo

Job Id:
168427

Job Category:

Job Location:
Clayton, North Carolina

Security Clearance:
No Clearance

Business Unit:
Piper Companies

Division:
Piper Clinical Solutions

Position Owner:
Rachel Buckle

Piper Companies is hiring a Lead Validation Specialist for a pharmaceutical and healthcare company that makes treatments for diabetes and chronic conditions located in Clayton, NC. The Lead Validation Specialist will assist with CQV activities in a sterile fill-finish facility. The Lead Validation Specialist will work onsite in Clayton, NC in a one-year contract role.


Responsibilities of the Lead Validation Specialist:

·      Carry out equipment and system testing to confirm they are ready for operational use (IQ, OQ, PQ).

·      Prepare and document validation activities, including test protocols and final reports.

·      Make sure all systems operate in line with regulatory and quality standards.

·      Troubleshoot issues that arise during validation and manage corrective actions as needed.

·      Work closely with internal teams and vendors to support validation and startup efforts.

·      Assist with key startup activities such as process validation, sterilization, and equipment commissioning.


Requirements of the Lead Validation Specialist:

·      7+ years of related experience

·      Bachelor’s degree

·      Experience qualifying various GMP systems

·      Familiarity with FDA GMP guidelines, EU Annex 1, and standard validation practices


Compensation for the Lead Validation Specialist:

·      $145,000 - $165,000 at an hourly pay rate

·      Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law


Keywords: Validation Engineer, CQV (Commissioning, Qualification, Validation), GMP (Good Manufacturing Practices), Process Validation, Pharmaceutical Manufacturing, Biotech, Life Sciences, Raleigh, RTP, Durham, NC


#LI-RB1

#LI-ONSITE


This job opens for applications on 7/10/26. Applications for this job will be accepted for at least 30 days from the posting date.

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