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Process Validation Scientist / Engineer for Biologics DP
CTCZurich Metropolitan Area, CHVor 30+ Tagen
StellenbeschreibungRelevant working / residency permit or Swiss / EU-Citizenship required. Engineer or Scientist, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with +4 years of experience in biopharmaceuticals or bachelor’s degree with + 8 Expertise in late-stage biologic DP manufacturing equipment and processes . Hands-on experience in other areas such as Quality, R&D and Manufacturing Operation is highly desirable Proven track record in atleast 3 of the mentioned areas : DP comparability, Equipment qualification , Pharmaceutical process development, Technology transfer, Process validation Demonstrated technical competency and experience with biologic DPs. Demonstrated experience in technology transfers projects. Partnering with R&D and commercial supply to improve the fit for plant and commercialization of new products into the supply chain. Demonstrated leadership in providing integration of activities, information across multifunctional groups and sites. Planning and logistics skills capable of effective integration of deliverables at the manufacturing site level. Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams. Ability to influence and lead peers, superiors, and external partners, including interaction with senior management. Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly. Ability to manage complexity and change. Collaborate and influence other functions / levels outside of own group and effectively leads cross functional and cross organizational teams to generally attain expected results for all parties. Travel to the manufacturer(s) as needed to provide on-site support or oversight, especially during qualification of equipment
Main Responsibilities :
- Support complex technology transfers with a focus on right-first-time execution and risk management.
- Author, review, and approval of technical and regulatory documents (e.g., SOPs, work instructions, batch records, validation protocols, control strategy, and reports).
- Support DP Process Performance Qualification and preparation of regulatory reports.
- Support the internal and external teams in qualification of DP manufacturing equipment.
- Perform as SME to identify technical areas for improvement, and supply chain improvement.
- As needed, provide SME input on change management, product impact assessment and implementation of changes to the DP manufacturing processes.
Qualifications and Experience :
years of experience