GMP | C&Q | Mechanical or Chemical Engineering | Dutch & English | CAPAs | Change Control | Deviations
Your new role
As commissioning and Qualification Engineer you will have a diverse range of responsibilities including the commissioning and qualification (C&Q) of various process and laboratory equipment in a GMP environment. You will design and execute process validation studies for the large scale API processes. Reviewing and assessing change controls for API processes to determine impact on validated state will also fall under your duties. You will apply Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements and participate in efficiency and streamlining projects to contribute to process improvement, technology transfer, new product introduction and other projects. Finally you will prepare, review and approve technical documents, procedures, CAPAs, change control, deviations, metrics etc.
What you'll need to succeed
You will need a degree in either Mechanical or Chemical Engineering with either Pharmaceutical, Biotech or Chemical experience and experience with sterile manufacturing C&Q is a plus. You will need a minimum of 3-5 years of experience with excellent communication skills in both English and Dutch. You have broad technical knowledge surrounding laboratory equipment and knowledge of computer system validation is an advantage.
Your new company
MSD is a leading company in global biopharmaceuticals with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. With 69,000 employees operating in more than 140 countries, MSD offers state-of-the-art laboratories, plants and offices that are designed to Inspire their employees as we learn, develop and grow.
In Oss, there are two large production sites that are formerly known as Organon. The first location, Biotech Operations, produces novel biologic active ingredients (“drug substance”). Their activities are split between USP (cell culturing/microbiology in bioreactors up to 22.000 liters) and DSP (filtration and purification of product).The other location, Pharmaceutical Operations, focuses on the production, packaging and distribution of various end products (tablets and injectables) and birth control products.
What you'll get in return
Hays Detachering | This is a project that will start with a contract for 12 months through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary and your travel expenses are covered.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1045815
Scientific and R&D
Competitive Salary + Travel expenses covered
Talk to a consultant
Talk to Tom Murphy, the specialist consultant managing this position, located in Amsterdam