Project Engineer - CAPEX (m/f/d)

Responsibilities

• Define technical requirements and success criteria aligned with GMP standards and operational objectives
• Develop and manage the full project roadmap from concept design through performance qualification (PQ)
• Act as the main technical point of contact for all mechanical adaptations and process improvements
• Ensure compliance with GMP regulations and internal quality standards
• Manage and coordinate change control processes in collaboration with QA
• Align and coordinate cross-functional teams across operations, engineering, maintenance, and quality
• Monitor project progress, timelines, budgets, and key milestones
• Conduct risk assessments and implement mitigation strategies
• Lead commissioning and qualification activities including IQ, OQ, and PQ
• Collaborate with validation teams to ensure effectiveness and compliance of implemented changes

Profile

• Bachelor’s or Master’s degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or related field
• Solid experience in biopharmaceutical manufacturing or GMP-regulated environments
• Proven track record in technical project management or operational excellence initiatives
• Strong experience with GMP processes, change management, and CQV activities
• Solid understanding of commissioning, qualification, and validation methodologies
• Strong project management and organizational skills with the ability to manage multiple workstreams
• Excellent problem-solving skills in complex and fast-paced environments
• Strong communication and stakeholder management capabilities
• Fluent German preferred and strong English skills required

Benefits

• Opportunity to work on high-impact projects in a GMP-regulated biopharma environment
• Exposure to complex, cross-functional projects with strategic relevance
• Professional development and continuous learning opportunities
• Collaborative and international work environment