Aseptic Filling Line Operators, Drug Product Manufacturing
Oferta en Dinamarca de Ingenieros industriales y de producción
Clasificación del trabajo: Profesionales científicos e intelectuales : Profesionales de las ciencias y de la ingeniería : Ingenieros (excluyendo electrotecnólogos) : Ingenieros industriales y de producción.
Arbejde, der forudsætter viden på højeste niveau inden for pågældende område : Arbejde inden for naturvidenskab og ingeniørvirksomhed : Ingeniørarbejde (undtagen inden for elektroteknologi) : Ingeniørarbejde i industri og produktion
Descripción de la oferta de trabajo:
Do you want to become one of the first filling line operators at the future Aseptic Filling Line at FUJIFILM Diosynth Biotechnologies in Hillerød? If you have extensive experience and strong knowledge from working with filling lines in Isolators and also have extensive GMP understanding as well as understanding working under Aseptic conditions, we would be delighted to have you on our team as Manufacturing Associate in the Drug Product Manufacturing (DPM) Business Unit.
We are just about to start the construction and building of our world class Drug Product Filling Facility and here we will have great opportunities for the right candidates to become a member of a totally new established Drug Product Manufacturing (DPM) team. Within the next 1 – 1½ year we will look for experienced Manufacturing Associates, Supervisors and Compliance Associates in the areas of Wash & Sterilisation, Formulation, Filling, Inspection and Compliance.
We are looking for team players, entrepreneurs and people who both like details and like taking greater responsibility beyond your scope of work. We are looking for people with “Genki”, which is one of our four values and is Japanese for passion, energy and fun. We believe in team work, high degree of delegation, giving responsibility to those closest to the work. We believe in people!
If any of these positions could have your interest, please do not hesitate to upload already now your CV and cover letter marked “DPM” and we will contact you when a relevant position becomes vacant
ASEPTIC FILLING LINE OPERATORS
But as an experienced Aseptic Filling line operator you can already now join our Drug Product Manufacturing team. Currently we are looking for Manufacturing Associates to support the project in relation to the design and lay-out of the filling line, setting up the team and the department, transitioning into the role as filling operator at the end of the project phase.
You will participate in setting up the manufacturing operating structure, equipment configurations and preparing the extensive document package. Further you will be involved in Mock-Up testing in Germany early 2021 as part of the design and configuration of our new fully automatic filling line.
As part of the role you will also be partly included in the Manufacturing teams in Drug Substance (DSM) and/or Finished Goods (FGM) as the roles in DPM is not full time during the first year of employment as a result of the DPM facility is being constructed and build.
Primary tasks will be:
- Ensure training compliance for assigned curriculum prior to performing any work task
- Set-up, Operation, and troubleshooting of filling line equipment: including perform format changes, line clearance, EM sampling, cleaning of filling machine and filling suite interior, etc.
- Documentation of perform tasks as per established Good Documentation Practices, and review of executed documentation (batch records, logbooks, etc.) in a timely manner
- Training and education of new and less experienced filling operators
- Assist in the execution of equipment/process qualification, media fills, validation, and protocols as required
- Development and creation of departmental procedures to include but not limited to SOPs, OJTs, and work instruction documents
- Participate in investigations, and execute appropriate approved corrective / preventative actions for Aseptic Core related processes
At this time in the project phase there is no fixed work schedule established and as mentioned you will partly be involved in the DSM or FGM operational teams during the first year of employment. Drug Product Manufacturing will run 24 hours a day all year around. There will be fixed day, evening and night shifts working 7 days out of 14.
THE DRUG PRODUCT MANUFACTURING TEAM
The Drug Product Manufacturing Team will consist of approx. 45 dedicated and enthusiastic employees when the first filling suite is ready for production. DPM will contain five teams covering Wash & Sterilization, Formulation, Filling, Inspection and Compliance. The common denominator of the five teams is the acknowledgement and development of each and every employee and the diversity of the employees who have different experiences and educational backgrounds, but collaborate closely on getting our medicine safely and quickly to the market.
Manufacturing Associates in our Drug Product Filling line will be fully capable of operating state of the art automated filling line equipment as well as ensure all process documentation and EM samples are being executed as per relevant operating procedures. The Filling Team is part of the Drug Product Manufacturing department within our Supply Chain which provides e.g. Drug Product filling services to our customers. The department continuously strives to identify opportunities to improve systems and practices to optimize and streamline our operation.
Please upload your CV and cover letter as soon as possible and latest by December 13th. We will screen candidates on a continuous basis.
For further questions about the operator positions, please contact Palle Gregersen, Head of Drug Product Manufacturing by mail at palle.gregersenfujifilm.com (for interested candidates only).
FUJIFILM Diosynth Biotechnologies is an industry-leading biologics Contract Development and Manufacturing Organization (CDMO) with global locations including one in Hillerød, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies. Among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems.
Our manufacturing site in Hillerød, Denmark, is a large-scale manufacturing facility with a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use.
FUJIFILM Corporation has announced the investment of approx. 6 billion DKK. into the site to double the manufacturing capacity, to add a fill finish capacity and to enhance the assembly, label and pack services on site. The current organization is approximately 800 employees and will grow significantly as a result of the investments. The company takes pride in enriching their communities, caring for their environment, and cultivating a world of opportunity for future generations.
At FUJIFILM Diosynth Biotechnologies, you will gain hands-on experience in an industry-leading biologics Contract Development and Manufacturing Organization. We aim to foster a collaborative, innovative, diverse and rewarding environment, where it is possible for employees to develop personally and learn. They can pursue their fullest potential as individual contributors and team members. Customer trust, digitalization, best place to work and expansion of capacity and end-to-end capabilities are cornerstones of the Fujifilm Diosynth Biotechnologies strategy in Hillerød, DK.
País del trabajo: Dinamarca.
Número de puestos: 1.
Empleador: VALTECH A/S.
Instrucciones para solicitar:
Please apply using one of the specified channels
Forma de contacto:
- Ciudad: København K; Código postal: 1437; Calle: Kanonbådsvej, Número: 2
- Sitio web: https://fujifilmdiosynth.com/career/aseptic-filling-line-operators-drug-product-manufacturing/
Identificador de la vacante:5248771.
Ver las 207 ofertas de trabajo de Profesionales científicos e intelectuales : Profesionales de las ciencias y de la ingeniería : Ingenieros (excluyendo electrotecnólogos) : Ingenieros industriales y de producción ofertadas.
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