Description

Manage qualification and validation of laboratory equipment and manufacturing systems within a regulated environment.

This role is on-site.

Responsibilities

• Qualify manufacturing facilities, utilities, temperature-controlled chambers, and GMP storage areas.
• Write and execute system validation and equipment qualification documents.
• Manage change controls, investigations, and CAPAs using quality management systems.
• Evaluate new computerized systems to identify and mitigate compliance gaps.
• Review and approve controlled documents through enterprise content management platforms.

Required Skills

• 7+ years of experience in an FDA-regulated GMP lab environment.
• Strong knowledge of cGXP requirements and good documentation practices.
• Advanced knowledge of 21 CFR Part 11 compliance and Data Integrity requirements.
• Experience validating common lab equipment and stand-alone computerized lab systems.
• Proficiency with quality management software such as eQRMS or TrackWise.
• Experience using content management platforms like VeevaVault or Documentum.
• Technical writing expertise for document development and report generation.
• Ability to interpret engineering manuals and technical drawings.

Key Skills

Education

Any Graduate