Validation Compliance Lead / Analyst

Katalyst HealthCares & Life Sciences; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

A healthcare company in the United States is seeking an experienced Validation Lead to manage validation activities ensuring compliance with GMP and GxP regulations. The ideal candidate will have a strong background in validation processes and will lead cross-functional teams. Responsibilities also include mentoring junior members and providing technical expertise in validation. The position requires at least a bachelor's degree in a related field.

Qualifications

• Minimum bachelor's degree or equivalent in a relevant field.
• Experience with GMP and GxP regulatory standards.
• Strong background in validation processes.

Responsibilities

• Lead and manage validation activities for systems, equipment, and processes.
• Develop and execute validation plans, protocols, and reports.
• Coordinate with cross-functional teams to ensure validation deliverables.

Skills

GMP

GxP

Validation processes

Risk assessments

Education

Bachelor's degree in Computer Science or related field

Job description

Overview

We are seeking an experienced Validation Lead to oversee and lead validation activities in compliance with GMP (Good Manufacturing Practice) and GxP (Good Clinical / Laboratory Practice) regulations. The ideal candidate will have a strong background in managing validation processes for systems, equipment, and processes within regulated environments, ensuring compliance, quality, and safety standards are met.

Responsibilities

• Lead and manage validation activities for systems, equipment, and processes to meet GMP / GxP standards.
• Develop and execute validation plans, protocols, and reports.
• Coordinate with cross-functional teams (QA, IT, Operations) to ensure validation deliverables are completed on time.
• Perform risk assessments and gap analysis to ensure compliance with regulatory requirements.
• Provide technical expertise in validation processes and troubleshooting issues.
• Ensure all validation documentation is accurate, up-to-date, and in compliance with regulatory guidelines.
• Support internal audits and inspections related to validation.
• Mentor and guide junior team members in validation activities.

Qualifications

• At least a bachelor\'s degree (or equivalent experience) in Computer Science, Software / Electronics Engineering, Information Systems, or a closely related field is required for the project.
• Mandatory Skills : GMP / GXP.