At nemensis ag, we connected thousands of applicants with their dream jobs and gave them the opportunity to develop or re-enter the job market. For our client, an international pharmaceutical company in Lucerne, we are looking for aChemical Engineer forExternal Manufacturing.
The successful candidate will assist the site tech ops leads in their responsibilities for the management of the technical interface between the company and the External Partners supportingcommercial and clinical manufacturing operations.
- Works closely with assigned site tech ops lead for day to day responsibilities
- Supports facility start-up and technical transfer to an External Partners for new products and/or provide global technical operations support for continuous commercial manufacturing at an External Partners for existing products
- Supports validation strategies for new and existing products
- Support internal and external changes to ensure compliant manufacture of products
- Performs reviews of external partner documents including but not limited to, change controls, batch records, validation studies and technical communications.
- Troubleshoot manufacturing issues and support investigations through scientific problem solving approaches
- Understands regulatory requirements and partners with Operations andQuality
- Ensure the highest Quality, Compliance and Safety standards by participating and complying with Manufacturing Division Quality Management System (QMS) requirements
- Qualified candidates must have a minimum BS in chemical/biochemical engineering, pharmaceutical science or chemistry/biology or related disciplines
- Minimum of six months of experience supporting the areas of bulk biologics manufacturing, technical transfer , or have demonstrated experience in these areas: process validation, process scale up, process engineering
- Preferredto have previous experience in External Manufacturing, Change Control Management, Deviation management, Validation and Statistical analysis
- Must be able to multi-task and work within tight deadlines
- This position requires flexibility and the ability to work independently, as well as excellent organizational skills
- Strong professional and interpersonal communication skills are also required
- Travel will be a requirement of this position at least 30% (primarily EU).
At nemensis ag you are always welcome with your personality, your ambitions and your professional experience. Share your expertise with us and apply now.
- Bulk biologics manufacturing
- Process validation
- Process scale up
- Process engineering
- External Manufacturing
- Change Control Management
- Deviation management
- Statistical analysis