Beschreibung
Entreprise :
For our client, a leading international pharmaceutical company with modern offices in the canton of Lucerne, we are currently looking for a Process Engineer (m/f/d) within the Large Molecule Technical Operations department to support drug substance tech transfer and commercial manufacture, to start immediately for the next 12 months. Depending on the performance and motivation, the possibility of an extension is given.
Description du poste :
The Process Engineer (m/f/d) will help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate.
Our client offers an extensive range of facilities and environments, whereas the selected candidate will have opportunities to work across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
* Works with external partners to achieve business goals and to establish a common culture
* Leads and acts as the primary interface on technical issues between technical operations and external partner drug substance manufacturers
* Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
* Responsible for technical activities for the commercial manufacturing process at the external partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events
* Develops solutions to complex technical issues that require a high degree of ingenuity, creativity and innovation.
* Provides on-site coverage at external partner in support of commercial and / or tech transfer person in plant activities
* Translates understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with operations, quality, and external partners
* Ensures that external partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with operations, quality, and regulatory
* Responsible for participation in creating, sharing, and adopting best practices and business process strategies
Description du profil :
To be considered for this position, the ideal candidate must have:
* Successfully completed bachelor's degree in chemical/biochemical engineering, pharmaceutical science, or chemistry/biology, or other related science or engineering field
* At leas 3 years of working experience in technical operations, pharmaceutical, upstream and downstream
* Excellent command of English (both written and oral), German would be an advantage
* Ability to work independently as well as excellent organizational skills
* Strong professional and interpersonal communication skills
* Ability to multi-task and work within tight deadlines
* Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation
* Proven team building skills
This position offers high flexibility with a possibility to work 100% remotely. Whereas a willingness to travel is required (approximately 20%).