AL
Specialist Engineer HVAC & WFI (gn)
ageneo Life Science Experts (Interim Solutions) GmbH
On-site Full-time Mid Level 4mo ago
About the role
About the Company
Vertically integrated biotechnology company aiming to unlock the potential of radiopharmaceuticals for patients. Over 20 years of continuous development of a holistic business model, starting with the production of radioisotopes and the development of proprietary radiopharmaceutical products for diagnostics and therapy.
Your Responsibilities
As Specialist Engineer HVAC & WFI (m/f/d), you will be responsible for the technical operation, maintenance, and optimization of central supply systems in a pharmaceutical production environment. Your tasks include, among others:
Technical Support & Maintenance
- Independent support of the supply technology with a focus on climate and ventilation systems (HVAC) as well as pure media systems such as WFI (Water for Injection)
- Planning, coordination, and execution of maintenance measures
- Recording and processing of technical issues, changes, and optimizations, taking regulatory requirements (including GMP) into account
Qualification, Documentation & Compliance
- Creation, revision, and maintenance of SOPs, work instructions, and qualifying and validating documents
- Participation in qualification and validation processes for HVAC and WFI systems
- Support during audits, inspections, and ensuring GMP compliance
Collaboration & Interfaces
- Close collaboration with internal departments, external partners, and technical service providers
- Solution-oriented communication to ensure efficient and safe plant operation
Your Profile
- Completed engineering degree (e.g., process engineering, mechanical engineering, pharmaceutical technology) or comparable qualification with relevant professional experience
- Sound technical know-how in supply technology (HVAC) and/or pharmaceutical pure media systems such as WFI
- Experience in a GMP-regulated environment is an advantage
- Structured, solution-oriented way of working with a hands-on mentality
- Very good German and English skills, both written and spoken
- Confident use of MS Office and relevant technical documentation systems
Benefits
- A demanding and varied position with scope for design
- A dynamic, international working environment with modern structures
- Extensive onboarding, training, and development opportunities
- Open corporate culture and short decision-making processes
Skills
GMPHVACMS OfficeWFI
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