Validation Specialist GMP Lab Equipment

Validation Specialist - GMP Lab Equipment Intellectt Inc Indianapolis, IN Job Details Contract $50 - $54 an hour 13 hours ago Qualifications Document compliance management Laboratory equipment performance testing and validation Laboratory instrument validation Equipment troubleshooting

GMP CMMS

Compliance documentation Commissioning phase involvement Pharmaceutical manufacturing facility experience Laboratory compliance and regulatory documentation Full Job Description Job Overview We are seeking a skilled Validation Specialist to support a large-scale laboratory expansion and site build-out project. This role will play a key part in qualifying and validating approximately 200 GMP laboratory instruments, primarily HPLC systems, within a pharmaceutical environment. This is a high-impact opportunity to contribute to a new facility startup while working with modern, paperless validation systems. Key Responsibilities Validation & Qualification Develop, author, and execute validation protocols (IQ/OQ) Perform qualification of GMP laboratory instruments (HPLC preferred) Manage validation documentation and ensure compliance with GMP standards Systems & Documentation Utilize electronic validation systems such as KNEAT Maintain equipment data in CMMS systems (e.g., GMARS or similar) Support paperless validation platforms (Veeva, ValGenesis) Equipment & Vendor Coordination Coordinate with vendors for installation, setup, and troubleshooting Participate in FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) Support equipment qualification and verification activities Lab Readiness & Site Support Assist in lab startup and site readiness activities Support CAPEX equipment validation projects Contribute to commissioning and operational readiness Required Qualifications Experience with GMP validation and equipment qualification Hands-on experience with IQ/OQ protocol writing and execution Strong knowledge of laboratory instrumentation (HPLC preferred) Understanding of validation lifecycle and compliance standards Experience with CMMS systems Preferred Qualifications Experience with KNEAT or similar validation systems Familiarity with Veeva or ValGenesis Experience supporting large-scale validation or CAPEX projects Background in lab startup, expansion, or site readiness

Pay:

$50.00 - $54.00 per hour

Work Location:

In person