Job Description

Purpose

Seeking a highly skilled and motivated Commissioning & Qualification Engineer to join the Visual Inspection (VI) Equipment project team. This role involves ensuring the successful commissioning, qualification, and ongoing validation of Visual Inspection equipment, systems, and processes to comply with regulatory standards and ensure the highest levels of quality. As a member of the team, C&Q Engineer will play a crucial role in supporting the setup, qualification, validation, and maintenance of Automated Visual Inspection (AVI), Semi-Automated Visual Inspection (SVI), and Container Closure Integrity Testing (CCIT) equipment, including Vacuum Decay and High Voltage Leak Detection (HVLD) systems. This role will play a critical part in ensuring equipment is properly installed, qualified, and validated in compliance with industry regulations and company requirements. The C&Q Engineer is responsible for execution and support coordination of the defined C&Q scope of their process area and meeting the agreed objectives regarding time schedule and functionality according to URS, Risk Assessments and Verification Plans. The C&Q Engineer will support the C&Q lead for execution scope under responsibilities of third parties.

Responsibilities:

Automated Visual Inspection (AVI) machines - Vial and Pre-filled Syringe (PFS) Semi-Automated Visual Inspection (SVI) machines CCIT equipment (Vacuum Decay and HVLD) Supporting Equipment (e.g. Lux meters) Plan, coordinate, and execute commissioning, and qualification activities for Visual Inspection (VI) systems, equipment, and support utilities/equipment as needed. Ensure that CQV activities are executed in accordance with CORP 35 per the C&Q Plan and supporting Validation Plans. Execution of the commissioning activities related to allocated areas or systems. Coordination of execution activities with supporting CSV Team and global IT teams. Lead C&Q testing activities supported by external vendors and/or contractors Develop any supporting validation plans related to scope of execution. Develop and review Qualification Protocols (IQ/OQ/PQ), commissioning documents, and final reports, ensuring compliance with relevant standards (GxP, FDA, EMA, USP, ISO, etc.). Ensure all activities meet relevant regulatory guidelines and company SOPs. Maintain an up-to-date knowledge of GMP, GxP, and other relevant regulatory requirements. Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle. Contribute to continuous improvement initiatives within the Visual Inspection (VI) C&Q environment, identifying opportunities for optimization in commissioning, qualification, and validation processes. Interface with other disciplines: HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc. Lead coordination meetings to fine-tune the commissioning preparation and execution with all involved parties. Maintain and reporting of C&Q status to the C&Q Lead, which can be reported into project stakeholders meetings (e.g. Tier 1 meetings, Wall meetings). Generate, review, approve, CQV test scripts in accordance with Verification Plans and any applicable site commissioning or validation plans or procedures. Ensure discrepancies encountered are developed, adequately reviewed and approved in accordance with CORP-35. Tracking of these deficiencies, including planning and executing the remediation actions Identify potential risks or issues during commissioning and qualification activities and lead troubleshooting efforts when necessary. Implement corrective actions as needed. Assist the C&Q Lead with the Handover and Release process. Lead the management of change for their area elements and ensures that the change is controlled, communicated and implemented in the most cost effective and timely manner Ensure C&Q execution milestones are completed as per baseline schedule. Ensure that quality standards are followed during C&Q execution. No significant observations in external regulatory inspections for allocated process area.

Qualifications

A relevant Third Level or Professional Qualification Engineering, Life Sciences, or a related field (e.g., Chemistry, Biotechnology, Pharmaceutical Sciences). Familiarity with Visual Inspection (VI) Equipment such as Automated Visual Inspection machines, Semi-Automated Visual Inspection (SVI) machines and/or Container Closure Integrity Testing (CCIT) equipment (e.g. Vacuum Decay or High Voltage Leak Detection (HVLD) systems). Proven experience (minimum 5 years) in commissioning, qualification, or validation within a GMP-regulated environment, preferably within the pharmaceutical, biotechnology, or medical device industry. Previous experience in authoring CQV lifecycle documents necessary. Familiarity with GxP (Good Manufacturing Practice), FDA, EMA, ISO standards, and other relevant regulatory frameworks. Experience in the preparation and review of IQ/OQ/PQ protocols and reports. Ability to work well under pressure and within strict deadlines Excellent problem-solving skills and ability to troubleshoot complex systems. Strong communication skills (both written and verbal), with the ability to interact with cross-functional teams and external vendors. Proactive and working independently Good Level in English, written and spoken / German a plus. Understanding of Knapp Validation methodology for Visual Inspection is a plus. * Experience in use of Kneat for documentation development and execution (not mandatory).