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Intellectt INC
Commissioning & Qualification EngineerIntellectt INC • Lehigh valley, PA, United States
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Commissioning & Qualification Engineer

Commissioning & Qualification Engineer

Intellectt INC • Lehigh valley, PA, United States
8 days ago
Job type
  • Full-time
  • Part-time
  • Temporary
  • Quick Apply
Job description
Commissioning & Qualification (C&Q) Engineer
Location: Pennsylvania (Onsite)
Type: Contract (W2, Multiple Openings)
We are looking for experienced C&Q professionals to support aseptic manufacturing operations in a regulated life sciences environment, focusing on commissioning, qualification, and validation of systems and equipment.
Key Responsibilities:
Execute commissioning and qualification (IQ/OQ/PQ) for equipment, utilities, and systems
Develop and review validation protocols and documentation
Support startup and validation of utilities (WFI, clean steam, process gases)
Perform qualification of lab instruments and analytical equipment
Collaborate with Engineering, Quality, and Manufacturing teams
Ensure compliance with GxP, FDA, and regulatory standards
Utilize e-validation systems (e.g., Kneat) for documentation
Troubleshoot issues during validation and support resolution
Maintain accurate documentation for audits and inspections
Requirements:
5+ years of experience in C&Q/Validation (Pharma/Biotech)
Strong knowledge of GxP, FDA regulations, and validation lifecycle
Hands-on experience in aseptic manufacturing environments
Experience with black utilities (WFI, clean steam) and/or lab equipment qualification
Familiarity with Kneat or similar e-validation tools preferred
Bachelor's degree in Engineering, Life Sciences, or related field

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Commissioning & Qualification Engineer • Lehigh valley, PA, United States

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