Ph3Role Overview /h3 pWe are seeking an experienced Project Engineer to support capital investment projects within a commercial mammalian cell production environment. This role combines technical expertise, operational excellence, and project management to ensure the successful delivery of mechanical adaptations, operational improvements, and GMP‑compliant project execution. /p pThe Project Engineer will act as the key interface between Operations, Engineering, Quality Assurance, Maintenance, Validation teams, and external Engineering Partners throughout the full project lifecycle — from conceptual design through commissioning and performance qualification (PQ). /p h3Responsibilities /h3 ul liDefine technical project requirements, success criteria, and implementation strategies aligned with GMP standards and operational objectives. /li liSupport and coordinate capital investment projects, ensuring activities are delivered on time, within scope, and within budget. /li liAct as the primary technical contact for mechanical adaptations, operational improvements, and production‑related engineering activities. /li liCollaborate cross‑functionally with Operations, Maintenance, Engineering, Validation, and QA teams to ensure seamless project execution and integration into production. /li liManage and support GMP change control activities, including Technical Change Requests (TCRs) and Change Records (CRs). /li liLead or coordinate commissioning and qualification activities including IQ, OQ, and PQ. /li liConduct risk assessments, troubleshoot technical challenges, and implement mitigation plans where required. /li liProvide technical guidance and regular project updates to stakeholders throughout the project lifecycle. /li liEnsure all project activities comply with GMP regulations, internal quality standards, and validation requirements. /li /ul h3Requirements /h3 ul liBachelor’s or Master’s degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related technical discipline. /li liMinimum 5 years of experience within biopharmaceutical manufacturing or GMP‑regulated environments. /li liStrong experience in technical project management, operational excellence, and capital project execution. /li liHands‑on experience with commissioning, qualification, and validation (CQV) activities within GMP environments. /li liStrong knowledge of GMP regulations, change control processes, and biopharmaceutical manufacturing operations. /li liExcellent communication, stakeholder management, and cross‑functional coordination skills. /li liStrong problem‑solving abilities with a structured and detail‑oriented approach. /li liProfessional or fluent German is required. /li liEnglish is required. /li /ul pAre you interested? Go ahead and apply now or send CV to /p /p #J-18808-Ljbffr