Role Overview
We 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.
The 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).
Responsibilities
* Define technical project requirements, success criteria, and implementation strategies aligned with GMP standards and operational objectives.
* Support and coordinate capital investment projects, ensuring activities are delivered on time, within scope, and within budget.
* Act as the primary technical contact for mechanical adaptations, operational improvements, and production‑related engineering activities.
* Collaborate cross‑functionally with Operations, Maintenance, Engineering, Validation, and QA teams to ensure seamless project execution and integration into production.
* Manage and support GMP change control activities, including Technical Change Requests (TCRs) and Change Records (CRs).
* Lead or coordinate commissioning and qualification activities including IQ, OQ, and PQ.
* Conduct risk assessments, troubleshoot technical challenges, and implement mitigation plans where required.
* Provide technical guidance and regular project updates to stakeholders throughout the project lifecycle.
* Ensure all project activities comply with GMP regulations, internal quality standards, and validation requirements.
Requirements
* Bachelor’s or Master’s degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related technical discipline.
* Minimum 5 years of experience within biopharmaceutical manufacturing or GMP‑regulated environments.
* Strong experience in technical project management, operational excellence, and capital project execution.
* Hands‑on experience with commissioning, qualification, and validation (CQV) activities within GMP environments.
* Strong knowledge of GMP regulations, change control processes, and biopharmaceutical manufacturing operations.
* Excellent communication, stakeholder management, and cross‑functional coordination skills.
* Strong problem‑solving abilities with a structured and detail‑oriented approach.
* Professional or fluent German is required.
* English is required.
Are you interested? Go ahead and apply now or send CV to l.ormrod@panda-int.com
#J-18808-Ljbffr