Tasks

- Own, manage and deliver clean and process utility systems for Biopharmaceutical Facilities as project lead engineer during design, procurement, project execution and turn-over to operations
- Leading and guiding engineering partners, EPCMV contractors and equipment suppliers during the design and execution of CAPEX projects
- Interfacing and communicating effectively with stakeholders being involved such as project / design management, other discipline leads, MSAT, Operations & Maintenance Group, EHS, Qualification and QA
- Collaboration with all parties involved for tasks such as equipment and systems design, specification generation, tendering, expediting, FATs, SATs, commissioning, qualification and start up
- Reporting and providing input of status and forecast of utilities on cost and schedule
- Hands-on involvement in the creation and development of engineering documents and test plans
- Overseeing, aligning and reviewing of engineering documents created by the EPCMV contractor
- Making sure that internal standards and requirements are correctly incorporated
- Ensuring that designs follows good engineering practices, code and standards
- Organizes, leads and protocols coordination design review workshops and progress meetings
- Contributing and representing the engineering group at HAZOP and GMP risk analysis
- Ensuring incorporation of lesson learnt and required changes into design
- Performing reviews of vendor design deliverables, scope of work, constructability, and schedule

Qualifications

- University degree in process, mechanical engineering or equal
- High proficiency in general technical understanding and in depth knowledge of clean/process and black utility requirements for biopharmaceutical production facilities
- Comprehensive GMP skills and knowledge of pharmaceutical standard regulations and guidelines (ISPE, EU GMP Guidelines, ASME, CFR, etc.)
- Ability to drive commercial and schedule awareness during all phases of the project cycle
- Strong analytical thinking
- Organized and structured attention to details, quality and safety in design with excellent documentation skills
- Cross culturally aware and adaptable
- Willing to rise to new challenges and willing to take risks
- Self-starter, proactive, excellent in problem-solving and communication in a highly agile environment
- Business fluent in German and English