CQV Automation Engineer (Pharma)

Location: NY - Onsite

Duration: Long Term on W2

**No C2C**

We are looking for a skilled CQV Automation Engineer to oversee the commissioning, qualification, and validation of automated pharmaceutical equipment, with a focus on Auto Injector Assembly Machines and specialized machinery from Mikron and Harro Hofliger. The role involves leading CQV activities for automation systems, developing and executing protocols (IQ, OQ, PQ), and ensuring all equipment meets stringent regulatory requirements (FDA, GMP). You will be responsible for commissioning and validating machinery, troubleshooting issues, and ensuring that automation systems are fully integrated into manufacturing operations.

Key Responsibilities:

Lead the commissioning and qualification of automation systems and equipment, including Auto Injector Assembly Machines.
Execute CQV protocols (IQ, OQ, PQ) and develop validation documentation.
Collaborate with cross-functional teams to ensure the successful commissioning of equipment from Mikron and Harro Hofliger.
Ensure compliance with regulatory standards (FDA, GMP) and internal quality processes.
Perform risk assessments and manage any deviations during CQV activities.
Support troubleshooting and optimization of automated systems.

Requirements:

Bachelor’s degree in Engineering, Automation, or a related field.
Proven experience with CQV activities, particularly in automation systems for the pharmaceutical industry.
Hands-on experience with Mikron and Harro Hofliger equipment is highly desirable.
Strong knowledge of FDA, GMP, and other industry regulations.

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