Berlin-Based GMP Site Engineering Lead

We are supporting a growing biopharmaceutical manufacturing organisation as they prepare a GMP production site for operational readiness and long-term manufacturing operations.
The business is looking for a senior technical leader to build and lead the site Engineering, Facilities, Maintenance, Utilities and Technical Operations function. This person will be responsible for ensuring the site is safe, compliant, reliable and ready for GMP manufacturing .
This is a hands-on leadership role suited to someone who can operate in a site start-up / ramp-up environment , build structure from an early stage, and lead both strategic planning and day-to-day technical execution.
Responsibilities

• Build and lead the site Engineering, Facilities, Maintenance and Utilities organisation.
• Own GMP site readiness across facilities, utilities, automation interfaces, equipment, maintenance systems and technical infrastructure.
• Lead commissioning, qualification, performance qualification and inspection-readiness activities.
• Oversee clean utilities, black utilities, HVAC, electrical infrastructure, laboratory equipment and facility services.
• Develop maintenance strategies, spare parts models, asset lifecycle plans and CMMS governance.
• Ensure reliable operation of critical systems through preventive, corrective and emergency maintenance support.
• Provide technical leadership for automation and digital systems supporting manufacturing, utilities and environmental monitoring.
• Oversee BMS, EMS, PCS/SCADA, CMMS and related site technical platforms.
• Lead equipment and facility-related deviations, root cause investigations, CAPAs and change controls.
• Manage capital projects, site upgrades, facility modifications and technical improvement programmes.
• Partner closely with Manufacturing, Quality, MS&T, CQV, Automation, EHS, IT and external vendors.
• Lead site shutdown planning, contractor management, troubleshooting and operational support.
• Build a strong culture around safety, compliance, reliability and continuous improvement.
• Manage engineering budgets, resource planning, vendor performance and future capability development.
  

• Senior engineering, facilities, maintenance or technical operations leadership experience within pharmaceutical, biotech or regulated manufacturing.
• Strong background in GMP site operations, site start-up, facility readiness or manufacturing ramp-up.
• Experience leading multidisciplinary teams across engineering, maintenance, facilities, utilities, automation or project engineering.
• Strong knowledge of clean utilities, black utilities, HVAC, electrical systems, GMP facilities and asset reliability.
• Experience with commissioning, qualification, inspection readiness, deviations, CAPAs and change control.
• Good understanding of automation and site digital systems such as BMS, EMS, PCS/SCADA, CMMS or similar platforms.
• Proven ability to manage budgets, vendors, capital projects, maintenance programmes and technical risk.
• Strong stakeholder management skills with the ability to influence senior leadership and cross-functional teams.
• Comfortable working in a fast-moving, growing site environment where structure, ownership and flexibility are required.
• Degree in Engineering or a related technical discipline.
• German and English language skills strongly preferred.