Dear Job Seeker,
I hope you're doing well.
I am Abida Khan, Technical Recruiter. I am reaching out regarding an exciting opportunity for a Validation Specialist position with one of our prestigious medical device clients.
We are seeking professionals with experience in GMP equipment validation and qualification, IQ/OQ protocol development and execution, HPLC and laboratory instrumentation, validation lifecycle documentation, CMMS systems, and electronic validation platforms such as KNEAT, Veeva, or Val Genesis. Experience supporting CAPEX projects, commissioning activities, and lab startup or site readiness initiatives is highly preferred.
I would love to connect and discuss this opportunity in more detail. If you are interested, please share your updated resume at abida.khan@intellectt.com
I look forward to hearing from you.
Job Title: Validation Specialist- Indianapolis, IN
Core Responsibilities
• Develop, author, and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
• Support qualification of approximately 200 GMP laboratory instruments, primarily HPLC systems.
• Create, review, and manage validation documentation and qualification packages.
• Ensure validation activities comply with GMP standards and regulatory requirements.
• Utilize electronic validation systems such as KNEAT throughout the validation lifecycle.
• Maintain equipment records and data within CMMS systems such as GMARS or similar platforms.
• Support paperless validation environments including Veeva and Val Genesis.
• Coordinate with vendors for equipment installation, setup, troubleshooting, and qualification activities.
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Support capital equipment (CAPEX) validation, commissioning, and site startup initiatives.
• Assist with lab readiness and operational readiness activities for new and expanding facilities.
Required Qualifications
• Experience with GMP equipment validation and qualification.
• Proven experience writing and executing IQ/OQ protocols.
• Strong understanding of laboratory instrumentation, preferably HPLC systems.
• Familiarity with validation lifecycle documentation and GMP compliance standards.
• Experience working with CMMS systems.