Lead Validation Engineer (Lab Equipment)

Responsibilities:

• Lead a team to ensure lab and equipment compliance with regulations and company procedures.
• Manage validation and documentation for complex computer systems, equipment upgrades, and product updates.
• Draft and execute validation plans, requirements, test cases, and summary reports.
• Oversee change control processes for laboratory equipment and coordinate evaluations of proposed changes.
• Perform validation tasks for new or modified equipment, processes, procedures, and products.
• Delegate tasks to team members and coordinate validation testing activities.
• Conduct impact analysis for validation and change management.
• Manage document approval processes.
• Conduct regulatory impact assessments and make recommendations.
• Act as the Subject Matter Expert on lab equipment.

Requirements:

• 7+ years in a GMP-regulated environment (including internships or co-op work experience).
• Proven experience leading complex laboratory qualification projects.
• Expertise in authoring, editing, and executing validation documents for laboratory equipment.
• In-depth knowledge of FDA regulations, ISPE guidelines, ISO standards, GDP, and 21 CFR Part 11 compliance.

Skills:

• Strong leadership and team management
• Proficient in change management and regulatory compliance
• Excellent documentation and validation skills

This role demands an experienced professional capable of managing complex projects and ensuring regulatory compliance in a dynamic laboratory environment.

**NO SPONSORSHIP OFFERED FOR THIS ROLE**

If this is of interest to you then please send a CV to wesley.cann@darwinrecruitment.com

Darwin Recruitment is acting as an Employment Business in relation to this vacancy.