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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.com
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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.
Job Responsibilities: - 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.
Technical skills: - 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
Personal Skills: - Teamplayer - 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
wat bieden wij?
You are flexible and you will receive a lot in return. You will get an attractive salary package with extra benefits: - group insurance, - hospitalization, - meal vouchers, - trips or possibly a company car with fuel card, - representation costs - training, ...