Commissioning & Qualification (C&Q) Engineer

Hello,

I hope you're doing well.

My name is Bhanu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Commissioning & Qualification (C&Q) Engineer based in Upper Macungie Township, PA 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

bhanu@intellectt.com

Job Title: Commissioning & Qualification (C&Q) Engineer
Location: Upper Macungie Township, PA

Position Summary:

Seeking an experienced C&Q professional to support aseptic manufacturing operations. The role focuses on executing commissioning, qualification, and validation activities for critical systems, utilities, and lab equipment in a regulated life sciences environment.

Key Responsibilities:

• Execute C&Q activities for aseptic manufacturing equipment, utilities, and systems
• Develop and review IQ, OQ, and PQ protocols
• Support startup and validation of black utilities (WFI, clean steam, process gases)
• Perform qualification of laboratory instruments and equipment
• Collaborate with engineering, quality, and manufacturing teams
• Ensure compliance with GxP, FDA, and regulatory standards
• Use electronic validation systems (e.g., Kneat) for documentation
• Troubleshoot C&Q issues and support resolution
• Maintain audit-ready documentation

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field
• 5+ years of C&Q/validation experience in pharma/biotech
• Experience in aseptic manufacturing environments
• Strong knowledge of GxP, FDA regulations, and validation lifecycle
• Experience with black utilities and/or lab equipment qualification
• Familiarity with Kneat or similar systems preferred
• Strong communication, technical writing, and problem-solving skills

Thanks & Regards,

Ajay Bhanu
Senior Recruiter
Intellectt Inc
Bhanu@intellectt.com
Direct: 732 784 4384
Desk number: 732 412 6999- Ext: 159