Lead Validation Engineer (Lab Equipment)

Company Info
Darwin Recruitment
Maryland, United States

Phone: +441277638949
Web Site: www.darwinrecruitment.com

Company Profile

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Title:

Lead Validation Engineer (Lab Equipment)

Location:

Indianapolis, IN 

Job ID:

85617
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Job Description:

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.