- Degree in a Science or Engineering discipline with five or more years of applied experience in Pharma/ Biologics.
- Hands on Project experience.
- Experience with large Capital Equipment procurement ideally in Sterile filling or biologics manufacture.
- Excellent technical writing and communication skills.
- Proven ability to work successfully in a high paced matrix organisation.
- People management skills are an advantage.
- Flexibility of working hours will be required to accommodate project team activities and execution.
- Must be a self-starter with a pro-active approach with a strong track record of delivering on projects.
- Experience of projects in GMP regulatory environment.
- Sterile filling process knowledge highly desirable.
- Manufacturing experience would be an advantage.
- Knowledge of ASTM 2500 qualification.
- Basic understanding of Single Use Technology.
- Experience with interacting in multi disciplinary project teams.
- Understanding of .
- Proven track record on delivering on projects.
- Manage Cost and schedule of the specific systems you are responsible for to ensure on time and on budget delivery.
- Ensure project documents are written and approved to ensure equipment is designed per requirements.
- Coordinate activities from different contractors of deliver thos systems
- Partner with CQV engineers to qualify thos systems
- Lead FAT and SAT to ensure successful start up on site.
- Project manage specific scopes within the Capacity Expansion. Develop sufficient knowledge to be the SME of those particular systems
For further information contact Sean on 0949029944 or email CV to email@example.com