Project Lead Engineering, Validation, Maintenance & Facilities
Location Leiden (NL) - 40 hrs
HALIX is a fast growing, contract manufacturer focusing on viral and recombinant protein products. We have recently built a state-of-the-art clean room at the Bio Science Park in Leiden that is getting filled with exciting new vaccines, antibodies and protein products. At HALIX, we enable our customers to find cures for impactful diseases. To support our ambitions we are looking for a Project Lead Engineering, Validation, Maintenance & Facilities to join the team.
As a Project Lead EVM & Facilities at HALIX, you will be working in the Engineering, Validation, Maintenance and Facilities department (EVM & Facilities). The EVM & Facilities department is responsible for keeping the facilities and production equipment in the desired state.
In the position of Project Lead you will be responsible for the planning, execution and reporting of modifications and new (internal) multidisciplinary projects. Furthermore you will be the client’s single point of contact for the disciplines Engineering, Validation, Maintenance & Facilities for specific HALIX CDMO projects. You report directly to the Manager EVM & Facilities.
Your tasks
- Manage and coordinate multidisciplinary projects (Clean Utilities, Equipment)
- First point of contact for the CDMO Project Manager and thus representing the EVM & Facilities department in the project team.
- Create first high level design sketches
- Handling Change control procedures and risk management
- Aligning the Equipment and Utility availability with new CDMO project’s needs and overseeing follow up technical changes to meet production process requirements
- Planning and coordination for the implementation of new production equipment in coordination with Validation Engineers, Maintenance Engineer and project Engineers for the start-up of new CDMO projects.
- Creating order via systematic approach and continuous improvement
- Making progresses visible by creating control systems such as planning, dashboards and apply project management tools
- Overseeing technical deviations, change control and risk management during the project
- Periodically participating in the alarm response team
You have
- Academic bachelor with a technical training such as mechanical or Electrical engineering with additional training and experience in life sciences (biotechnology or related).
- A minimum of 5 years of experience in biotechnological pharmaceutical facilities.
- A minimum of 4 years of experience in Project Management
- Experience with biotechnological processes and CMC manufacturing.
- Proven experience of outsourcing critical work to contractors.
- Experiences work within budget to strict deadlines
- Working knowledge of GMP/FDA guidelines
- Good knowledge of English and Dutch, both verbal and written.
- Proficiency in Microsoft Office Suite and Microsoft
- Project or equivalent project management tool is required
Who are we looking for?
Our new team member is an experienced (Sr) Facility Engineer or technical Project Engineer with a mechanical or electrical background. You have a pro-active and decision making mindset and are able to adapt in a dynamic GMP environment. You are a strong communicator and you have strong organizational skills with regards to multidisciplinary projects.
Our offer
- You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
- A culture that is characterized by entrepreneurial spirit and close and transparent communication. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
- You will be working in our dynamic headquarters in Leiden.
- Being part of a company that is focused on excellence in GMP Manufacturing.
- A competitive salary that matches your responsibilities and experience.
Your application
We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.
Important notice to search firms and recruitment agencies
HALIX does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HALIX Recruitment via recruitment@hal-allergy.com to enquire about a potential recruitment or search agreement with HALIX.
HALIX, Bioscience as a Service
HALIX is a fast growing, biopharmaceutical contract development and manufacturing organization (CDMO) focused on viral vector and recombinant protein products. We support our customers with the development & commercialization of biologics enabling the treatment & prevention of life threatening conditions such as cancer, COVID-19, influenza and other infectious diseases. Our state of the art GMP manufacturing facilities and our experienced and dedicated team of people ensures manufacturing capabilities which meet the highest quality standards, a service oriented way of working and a flexible mindset. If you too would like to become part of an innovative and challenging contract development and manufacturing organization (CDMO), then this is a perfect opportunity!
HALIX is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HALIX is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.
.jpg)