Commissioning and Qualification (C&Q) Specialist

Catalyx is seeking a hands-on Commissioning and Qualification (C&Q) Specialist to support commissioning, qualification, and startup. The ideal candidate will serve as the Subject Matter Expert (SME) for Cognex Vision Systems, while also supporting PLC/HMI troubleshooting, and providing cross-functional communication between the C&Q and Automation teams. Experience with Systech Serialization Systems is a strong plus.

Key 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 Bachelor’s 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.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.