Process Innovation Specialist

We are seeking a highly skilled Process Development Expert to join our Innovative Formulations department.

As a Process Development Expert, you will be responsible for the design of process transfer from small to industrial scale and participate in the establishment of custom made industrial equipment/facilities.

1. Design the process transfer from small to industrial scale in collaboration with the R&D teams
2. Supervise the execution of the process transfer trials
3. Develop process flow diagrams and in process control strategies
4. Prepare process transfer plans and protocols
5. Review and approve process transfer batch records and reports
6. Support the manufacturing of the process validation batches
7. Review process validation protocols and reports
8. Contribute to the development of batch manufacturing master documents
9. Assess batch manufacturing data, participate in manufacturing investigation and recommend process improvements
10. Contribute to the design of custom equipment/facilities (manufacturing skids and filling lines) and the preparation of the URS based of the development plan
11. Monitor the construction of the custom equipment/facilities and respond for process related aspects
12. Contribute to FAT, SAT, IQ/OQ of new equipment/facilities
13. Prepare and/or review Qualification protocols and reports
14. Train production staff and new team members on the new processes
15. Follow the GMP and Quality standards of the manufacturing site
16. Participate in professional development activities/seminars to keep updated to latest technologies and developments in the field

The ideal candidate should have:

• BSc Degree in Chemical Engineering or relevant field
• 3-5 years experience in process development or process engineering in the pharmaceutical industry
• Hands-on experience with manufacturing processes (microspheres, suspensions, gels)
• Working knowledge of GMP regulations and ICH guidelines
• Experience with industrial equipment qualification
• Hands-on experience with the qualification of new equipment
• Familiarity with SAP system
• QA background will be considered an asset

The ideal candidate should possess:

• Excellent communication skills in English language (writing & speaking)
• Computer literacy
• Troubleshooting skills
• Demonstrated ability to work on multiple projects and meet timelines

You will gain:

• Involvement in a high-caliber, team-oriented and dynamic atmosphere
• Exposure to challenging business issues and practices
• Great opportunity to leverage and develop your business knowledge and skills

This is a great opportunity to innovate, make decisions, achieve your own potential and chart your own career path.

We are an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.