Senior Project Engineer
We are seeking a Senior Project Engineer to lead and deliver capital investment and process improvement projects within a GMP biologics manufacturing environment. The successful candidate will provide technical leadership from concept development through execution, ensuring projects are delivered safely, on time, within budget, and in compliance with GMP requirements.
This role requires a strong combination of process engineering expertise, project management capability, and biologics manufacturing knowledge, with direct exposure to upstream and downstream processing, clean utilities, and production facility modifications.
The Project Engineer will work within a cross-functional matrix organization, collaborating closely with Manufacturing, MSAT, Engineering, CQV, Automation, Quality, and external engineering contractors.
Key Responsibilities
- Lead the planning and execution of small to medium-sized CAPEX projects within GMP biologics manufacturing facilities.
- Manage project scope, budget, schedule, resources, risks, and stakeholder expectations.
- Coordinate multidisciplinary engineering teams and external contractors throughout the project lifecycle.
- Support equipment installations, facility modifications, production expansions, and process optimization initiatives.
- Ensure engineering solutions meet operational, quality, safety, and regulatory requirements.
- Drive commissioning, startup, operational readiness, and project handover activities
- Develop and evaluate engineering concepts for facility upgrades and process improvements.
- Perform technical and economic feasibility assessments.
- Prepare cost estimates, schedules, technical specifications, and business cases.
- Identify opportunities to improve manufacturing performance, reliability, and efficiency.
Requirements
- 8+ years of experience within the pharmaceutical, biotechnology, or CDMO industry.
- Proven experience delivering CAPEX and engineering projects in GMP-regulated facilities.
- English and German fluent