Lead Validation Engineer (Lab Equipment)

Lead Validation Engineer (Lab Equipment).

Lead Validation Engineer (Lab Equipment)

Indianapolis

|

Contract

|

CQV

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.

Wesley Cann

SUBMIT YOUR CV

Name_1
Max. file size: 512 MB.

UPLOAD CV WITH:

This field is for validation purposes and should be left unchanged.
Girl-on-iPad-New

SWEDISH TECH SALARY BENCHMARKS.

Group 365

Are you looking for a new role? Would you like to compare your current salary against the market rate?

Maybe you’re looking to grow your team and need help planning and setting hiring budgets.

Our interactive market update, split by technology, has all the information you need; from salary benchmarks, gender split and average tenure to 'time to hire' and fastest-growing skills.