Commissioning & Qualification Specialist
Commissioning & Qualification specialist
Within the Windmill Project Team you will participate in the new facility design and construction teams within the Biopharmaceutical division. There are numerous of openings, and based on your experience you can enter as a starter, or as an experience manager. You will work in a stimulating group of engineers, scientists and operators and will be able to grow both in your personal and technical skills.
As a Comissioning & Qualification specialist you will contribute to a number of projects in the field of commissioning and qualifying laboratory and process equipment in the Biopharmaceutical department. You will either manage teams to or perform tests yourself on the equipment according to the protocols in collaboration with colleagues from operations.
Responsibilities of the team:
*Please note that individual responsibilities will be based on experience*
- Plan and execute activities for (De-)Commissioning & Qualification activities within the biopharmaceutical site.
- Writing qualification Protocols and reports.
- Ensuring proper transfer of Qualification documents to the end users
- In collaboration with Project Engineers & End Users ensure the correct setting of equipment
- Review supplied Turn over packages from suppliers
- Developing Protocols for Life Cycle Development and Performance
- Proficiency in Microsoft office and job related computer applications.
- Gaining knowledge of the Six sigma methodology
- Customer service & liaison
- Effective time management and multi-tasking skills.
- Manage projects across multiple disciplines effectively
- Calibration and verification of equipment in the qualification (of e.g. autoclave) programs.
- Maintaining Compliance with all health and safety regulations.
- Implementing CAPAs (Corrective Action Preventative Actions) as a result of root cause analysis for out of specification results obtained.
- Completed Diploma in Engineering, Biochemistry, Applied Science or equivalent working and thinking level through work experience.
- Experience with Commissioning & Qualification within a (bio) pharmaceutical environment.
- Knowledge of GMP legislation
- Excellent control over the English language (and preferably Dutch)
- Good planning and (technical) writing skill
Contact Robert Bots on +31(0)20 530 58 88 or r.bots [@] progressiverecruitment.com