Responsibilities: - Remain onsite and embedded with the C&Q team on Line 8 to provide real-time support during commissioning and qualification activities.
- Act as the Cognex Vision Systems SME supporting setup configuration calibration and troubleshooting.
- Collaborate with the Automation team to resolve issues optimize system performance and implement updates or changes as needed.
- Support the integration and operation of Systech Serialization Systems (preferred).
- Assist with PLC/HMI troubleshooting and minor programming modifications.
- Participate in daily C&Q meetings document findings and track resolution of technical issues.
- Ensure compliance with GMP safety and regulatory standards during all activities.
- Provide technical input for deviation investigations risk assessments and change control.
- Support test execution and data collection for validation protocols as necessary.
Requirements: - Proven experience with Cognex Vision Systems in a GMP/regulatory manufacturing environment.
- Working knowledge of PLC (e.g. Allen-Bradley) and HMI systems.
- Strong troubleshooting and problem-solving skills in a high-speed automated packaging or manufacturing line.
- Effective communicator with the ability to interface between multiple departments (C&Q Automation QA Engineering).
- Experience with Systech Serialization Systems is a plus.
- Familiarity with commissioning and qualification methodologies (IQ/OQ/PQ).
Preferred Qualifications: - Associate or bachelors degree in engineering Automation or a related technical field.
- Previous experience in pharmaceutical biotech or regulated industries.
- Understanding of FDA cGMP 21 CFR Part 11 and validation lifecycle processes.
Responsibilities: Remain onsite and embedded with the C&Q team on Line 8 to provide real-time support during commissioning and qualification activities. Act as the Cognex Vision Systems SME supporting setup configuration calibration and troubleshooting. Collaborate with the Automation team to resol...
Responsibilities: - Remain onsite and embedded with the C&Q team on Line 8 to provide real-time support during commissioning and qualification activities.
- Act as the Cognex Vision Systems SME supporting setup configuration calibration and troubleshooting.
- Collaborate with the Automation team to resolve issues optimize system performance and implement updates or changes as needed.
- Support the integration and operation of Systech Serialization Systems (preferred).
- Assist with PLC/HMI troubleshooting and minor programming modifications.
- Participate in daily C&Q meetings document findings and track resolution of technical issues.
- Ensure compliance with GMP safety and regulatory standards during all activities.
- Provide technical input for deviation investigations risk assessments and change control.
- Support test execution and data collection for validation protocols as necessary.
Requirements: - Proven experience with Cognex Vision Systems in a GMP/regulatory manufacturing environment.
- Working knowledge of PLC (e.g. Allen-Bradley) and HMI systems.
- Strong troubleshooting and problem-solving skills in a high-speed automated packaging or manufacturing line.
- Effective communicator with the ability to interface between multiple departments (C&Q Automation QA Engineering).
- Experience with Systech Serialization Systems is a plus.
- Familiarity with commissioning and qualification methodologies (IQ/OQ/PQ).
Preferred Qualifications: - Associate or bachelors degree in engineering Automation or a related technical field.
- Previous experience in pharmaceutical biotech or regulated industries.
- Understanding of FDA cGMP 21 CFR Part 11 and validation lifecycle processes.
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