CQV Specialist

Hello,

I hope you're doing well.

My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a CQV Specialist based in Framingham, MA with one of our prestigious clients.

I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at vyshnavi.t@intellectt.com

Job Title: CQV Specialist
Location: Framingham, MA (Onsite)
Duration: 6+ months

Job Summary:
The CQV Specialist will support commissioning, qualification, and validation activities for utilities, equipment, and systems in a pharmaceutical manufacturing environment. The role involves protocol execution, documentation, and ensuring compliance with regulatory standards.

Key Responsibilities:

• Develop, write, and execute CQV protocols for utilities, equipment, and systems
• Prepare final reports including results, deviations, and resolutions
• Identify and resolve protocol discrepancies and deviations
• Review vendor validation documents for accuracy and compliance
• Apply risk-based approaches aligned with regulatory requirements
• Collaborate with cross-functional teams to meet project timelines
• Ensure accurate and compliant documentation

Required Qualifications:

• 4+ years of CQV/validation experience in pharma or biotech
• Hands-on experience with utilities, CIP/SIP, HVAC, fill-finish, CTUs, and formulation equipment
• Experience with digital platforms (e.g., Veeva and other tools)
• Strong communication and problem-solving skills

Preferred Qualifications:

• Bachelor's degree in a STEM field
• Knowledge of industry standards and risk-based validation approaches
• Strong organizational skills and attention to detail