Industrial Manufacturing Engineer.

For our client, an international company in Schaffhausen, we are looking for an
Industrial Manufacturing Engineer
 

• Start date: ASAP
• End: 1 year
• Extension: possible
• Workplace: Schaffhausen
• Workload: 100%

In this position, you will establish Manufacturing Science and Technology expertise across different equipment platforms for drug product development & manufacturing with focus on Parenterals. You will represent the DPDS pilot plant in development and clinical/commercial supply teams ensuring timely clinical supplies for drug product.


Requirements:

1. Ensure timely plant readiness to support experimental / clinical activities
2. Ensure timely delivery of clinical material from internal pilot plants
3. Provide pilot plant input & requirements to Drug Product Development (DPD) / Primary Container Development (PCD)
4. Support scale-up and Tech-Transfer
5. Acts as the tech transfer receiving party for pilot plants
6. Put relevant manufacturing information and technical capabilities in place for the operations team to flawlessly produce the DP according to GxP, EHS and business requirements
7. Ensures that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations
8. Review qualification documents, calibration, deviation handling and COC. Spokesperson during audits and inspections
9. Supports investigations, CAPAs, change controls according to assigned responsibilities and performs critical raw data review for key documents
10. Specialist for technology platforms being used within the Pilot Plant & across network

Qualifications

• You have a degree in Pharmaceutical/Biochemical/Chemical or relevant Sciences or comparable experience in pharmaceuticals or in a related field with demonstrated ability (3-5 years) OR a PhD with proven experience (1-3 years)
• Demonstrated proficiency and experience in biologics drug product development within the biopharmaceutical industry is helpful
• Demonstrated proficiency and experience of biopharmaceutical process design is helpful
• Solid understanding and experience of technology transfer operations is preferred
• Solid understanding and experience in fill/finish operations is preferred
• Proven track record of creativity and problem solving.
• Ability to collaborate with cross-functional teams is a must.
• Excellent oral and written language skills in German and English.