Expert Quality Engineering

ph3Aperún /h3 h3Summary /h3 pThe role will support the Quality oversight of Engineering and CSV activities at Incyte large scale biological manufacturing facility at Yverdon-les-Bains, Switzerland. /p pThe role will ensure QA deliverables related to classified rooms and utilities qualification, maintenance, calibration, equipment qualification, system validation and overall operational GMP readiness in accordance with cGMP regulations, company policies, and regulatory requirements. /p pThe role will ensure a strong collaboration with other Bioplant functions and will promote compliance, continuous improvement and Quality culture. /p h3Duties And Responsibilities /h3 ul liProvide Quality Assurance oversight for equipment and utilities throughout their lifecycle (including the Commissioning Qualification, Calibration and Maintenance activities). /li liReview and approve qualification documentation, including qualification protocols and reports. /li liDefine and support risk-based qualification and validation strategies. /li liEnsure equipment remains in a qualified state through effective management of maintenance, calibration, change control and periodic review activities. /li liAct as Subject Matter Expert (SME) for complex qualifications, validation and compliance topics. /li liProvide QA oversight for computerized functionalities associated with GxP equipment. /li liReview and approve CSV documentation related to equipment software and automated systems. /li liEnsure data integrity requirements are appropriately implemented and maintained throughout the equipment lifecycle. /li liAssess quality and compliance impacts associated with equipment implementation, modifications and upgrades. /li liReview and approve deviations, investigations, CAPAs, change controls and risk assessments related to equipment. /li liSupport the introduction of new laboratory and manufacturing equipment from a Quality Assurance perspective. /li liSupport complex and strategic quality initiatives related to equipment qualification, validation and compliance. /li liPartner with Engineering, Manufacturing, Maintenance and Validation stakeholders to proactively identify, mitigate and resolve quality and compliance risks related to GxP equipment. /li liReview and approve SOPs, work instructions and quality documentation related to equipment qualification, validation, maintenance and lifecycle management to ensure compliance with regulatory requirements and company procedures. /li liReview and approve periodic reviews, audit trail assessments and data integrity controls associated with computerized laboratory and manufacturing equipment within the area of responsibility. /li liEscalate significant quality and compliance risks related to equipment qualification, validation or computerized equipment to management as appropriate and support the definition of remediation actions. /li liParticipate in internal audits and regulatory inspections and support inspection readiness activities. /li liDrive continuous improvement initiatives related to equipment lifecycle management, validation processes and quality systems. /li liPromote quality culture and foster understanding and application of cGMP requirements, quality standards and validation principles across supported functions. /li liPromote risk-based, compliant and pragmatic approaches in accordance with GMP requirements and company standards. /li /ul pDelegate to: QA Engineering Specialist and QA Engineering CSV Manager /p h3Requirements /h3 ul liAcademic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering) /li liFirsthand experience of min 5 years in an Engineering / CSV position with confirmed experience in a Quality position /li liThorough knowledge in cGMP and international regulatory requirements /li liThorough knowledge in qualification and validation activities (equipment and computerized system) /li liFluent in French and English written and spoken /li liAbility to make pragmatic and compliant decisions /li liStrong result orientation and committed team member /li liGood written and verbal communication skills. /li /ul pDisclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. /p pWe Respect Your Privacy /p pLearn more at: /p pThe Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. /p pDuring the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. /p pYou may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. /p pYou can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable). /p pPlease contact if you have any questions or concerns or would like to exercise your rights. /p /p #J-18808-Ljbffr