Equipment Validation Specialist

cGxPServe; Portsmouth (NH); On-site; USD 70,000 - 100,000; Full time

Job summary

cGxPServe is seeking an Equipment Validation Specialist to ensure compliance and performance of GMP manufacturing equipment. The role requires a Bachelor’s degree and strong experience in validation and regulatory practices. You will collaborate with quality assurance and operations teams, contributing to product quality and audit readiness.

Qualifications

• Minimum of 4 years of experience in a manufacturing or GMP-regulated environment.
• Strong knowledge of equipment validation principles.
• Experience with regulatory compliance in quality assurance.

Responsibilities

• Perform equipment validation and requalification to ensure systems remain validated.
• Collaborate with Operations and Quality teams for compliance.
• Support the review of SOPs, protocols, and change controls.

Skills

Equipment validation principles

Regulatory standards

Quality Assurance

Education

Bachelor's degree

Tools

Document Management Systems (DMS)

LIMS

Track Wise

Job description

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Job Description

The Equipment Validation Specialist is responsible for ensuring that all critical GMP equipment and systems used in manufacturing are validated, maintained, and compliant with regulatory requirements. This role supports manufacturing operations by providing documented evidence that systems perform as intended, ensuring product quality and regulatory compliance.

Job Description

The Equipment Validation Specialist is responsible for ensuring that all critical GMP equipment and systems used in manufacturing are validated, maintained, and compliant with regulatory requirements. This role supports manufacturing operations by providing documented evidence that systems perform as intended, ensuring product quality and regulatory compliance.

Responsibilities

• Perform equipment validation and requalification to ensure systems remain in a validated state.
• Maintain and organize validation tools such as dataloggers and probes.
• Validate biopharmaceutical equipment including SIP systems, autoclaves, clean utilities, and temperature-controlled rooms.
• Develop and execute validation protocols based on engineering documentation and project plans.
• Support the review and approval of SOPs, protocols, change controls, deviations, and CAPAs.
• Perform quality system tasks using Document Management Systems (DMS), LIMS, and Track Wise
• Collaborate with Operations and Quality teams to ensure compliance and audit readiness.
• Complete other duties as assigned.
  
  

Requirements

• Bachelor's degree (strongly preferred).
• Minimum of 4 years of experience in a manufacturing or GMP-regulated environment.
• Working knowledge of equipment validation principles and regulatory standards.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Research Services

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