Lead Engineer

Vor 5 Tagen


Köln, Nordrhein-Westfalen, Deutschland Project Delivery Partners Vollzeit 60.000 € - 120.000 € pro Jahr

Overview:The Project Commissioning & Qualification (C&Q) Lead is accountable for managing the planning and execution of MedTech Facility projects at the Client's sites.The scope shall include utility, HVAC and cleanroom C&Q, including project planning, resource management, team training, field execution, reporting and close-out.This role is responsible for ensuring compliance with all applicable regulatory requirements, Quality standards, Global and site procedures and industry best practices.A suitable candidate for this role will be a self-starter with strong interpersonal, organizational, and technical skills.Key relationships include working closely with the Project Delivery Team, Project Controls, Engineering & Design, Construction Management, Site Engineering, Automation, Maintenance, Operations, and Quality functional groups.Key Responsibilities:Act as the primary C&Q Project Lead on MedTech Facility projects.Lead and manage teams of C&Q Engineers to deliver the C&Q project scope including.Lead and participate in the development and execution of C&Q documentation in accordance with internal Quality Standards, cGMP requirements, and client procedures.Manage C&Q team safety during the project.Manage scope execution in effectively scheduling, coordinating, mentoring and reviewing project activities with appropriate stakeholder groupsEffectively interact with project stakeholders to execute an effective, efficient and compliant C&Q program.Experience, Skills & Knowledge:Required:Minimum of years of relevant business experience with at least 3 years of leading C&Q Projects.Experience with current C&Q methods, including ISPE, ICH, and Risk-Based approach.Experience in C&Q schedule development and maintenance.Experience in leading groups of internal and external team members.Experience of MedTech projects focusing on Facility and Utility C&Q.Knowledge of local regulatory requirements.Excellent problem solving and troubleshooting abilities.Strong communication skills · Strong negotiation skillsPreferred:Prior experience managing major capital (>€10M) projects.Additional Requirements:Proficient in German and English.



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