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Diverse role in a growing, innovative biotech company
Het bedrijf / The company
The organisation is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. Their lead product is Ruconest™ (Rhucin® in non-European territories) which is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE. They are also developing the same recombinant protein in other indications, including pre-eclampsia and acute kidney injury. Furthermore, they investigate in the clinical efficacy of this recombinant protein in COVID-19. The organisation has specialized themselves in the production of protein therapeutics. Their innovative technology and processes are aimed at purification and formulation of these products. The organisation is poised for further scientific, technological and new product development and additional commercial rollouts. They are based internationally and growing quickly. As a result of this growth, they are looking for a CQV Engineer.
De functie / The role
As CQV Engineer you will arrange the commissioning, qualification and validation of all process equipment, facilities and utilities on the different sites (animal facilities, DSP and lab facilities) to ensure systems, facilities and equipment meet the design and performance requirements for users. Furthermore, you will coach the local team in the ongoing equipment re-qualification process, operations and performance requirements. Firstly, it is your responsibility to develop technical specifications and write the URS for equipment, systems and facilities to ensure that the intended processes can be executed and are in compliance. Secondly, you will write and execute qualification protocols (IOQ /PQ), including identification and resolution of non-conformances/deviations and changes and write summary reports for IOQ / PQ testing. Thirdly, you will perform risk assessments to provide equipment, systems and facilities qualification guidance. Fourth, you will advise facilities on issues related to equipment, systems and facilities and you will ensure that contractors perform equipment, systems and facilities qualifications adequately. Lastly, you will shape the architecture for qualification documentation, implement preventative and corrective actions related to CAPAs and provide improvement opportunities.
Het profiel / Your profile
• Bachelor’ or master’s degree in Biochemical Engineering, Chemical, Electrical, or Mechanical Engineering, Biotechnology or Life Sciences; engineering degree is preferred
• minimal 10 years of relevant working experience
• knowledgeable of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (EMA, FDA, ICH)
• a minimum of 5 years of cGMP CQV experience in different areas, like biotechnology, pharmaceutical production and laboratory
• experience with lean manufacturing principles (Green Belt certified is an advantage) and experience with regulatory inspections (is an advantage)
• strong problem analysing and solving skills
• decisive in decision making and adaptable in a fast-paced environment
• good professional and interpersonal communication skills; both oral and written in English and Dutch (French is an advantage)
Het aanbod / The offer
• a permanent position
• a challenging role in a growing biotech company
• an amazing opportunity to use your skills and experience
• function aimed at qualification and validation
• working in an international environment
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to WL/21-041-FMF to Djamila Hagemans: email@example.com.
For further information, please call Djamila Hagemans at number +31 (0)33 472 80 87.
Tenslotte ..... / Finally ....
An individual assessment may be part of the selection procedure.
Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.