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For one of the world's largest bio-pharmaceutical companies with a product range for all stages in life, a strong product pipeline and leading research and manufacturing capabilities, we are looking for a PROJECT ENGINEER (PRODUCT SUPPORT BIOLOGICALS).
Interested? Send your resume to email@example.comHelp
This role will require process validation and filing activities for internal projects (filling line transfers / batch size increase).
The position will require the application of process and product knowledge to ensure a successful validation of process changes on drug product manufacturing . It will require extensive team work and interaction with groups across the site and in the network.
- Perform risk based process validation
- Author of regulatory sections for authorities
- Provide technical input for material, in-process, release, and testing-related evaluations.
- Author and contribute to technical documentation This role will require process validation and filing activities for a new product into the site.
- University degree in scientific field: Industrial engineer, Industrial pharmacist, Civil engineer, Bio-engineer
- At least 2-3 years of relevant experience in projects in the pharmaceutical, chemical or other industry.
- Experience with (sterile) drug product is an asset as well as knowledge of Quality Systems, product testing/qualification
- Dynamic and enthusiastic.
- Respect for agreed timing and decisions.
- Respect for procedures and Good documentation practices
- Good communicator, convincing
- 'On the field' mentality
- Flexibile and agile
Salary and Benefits
You are flexible and you will receive a lot in return. You will get an attractive salary package with extra benefits:
- group insurance,
- meal vouchers,
- trips or possibly a company car with fuel card,
- representation costs
- training, ...