A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit Position Summary: The individual will be the Computer Software Assurance (CSA) Analyst across Resilience Digital Applications, and Integration predominantly supporting site located in West Chester, Ohio. The preferred candidate will collaborate with global and site stakeholders such as the system owner, process owner, quality, engineering, and manufacturing to develop a highly effective validation program by adopting global standards and processes. The incumbent shall always consider critical thinking and a risk-based approach during every aspect of the system lifecycle. This is a site based position in West Chester, OH. Position Responsibilities: Provides Computer Systems Validation support for Digital Systems and Technology Solutions. Develop and apply a risk-based methodology to assurance/validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5. Use knowledge and expertise in blending traditional GAMP5/CSV/CSA principles and practices with an agile QRM approach in the right proportions to fit large, complex, mission-critical, site or enterprise-level applications. Oversee activities of Digital GxP compliance and work closely with the Manufacturing Applications team, Digital Security, Digital Operations, Project Management teams, and third-party vendor teams to ensure coverage and consistency in testing. Support the development of policy, process, and procedures of computer systems validation (CSV) programs. Create, review, and update computer system lifecycle documentation (SDLC) deliverables (e.g. validation plans, business process maps, data flow diagrams, user acceptance tests). Ensure computer systems are validated and maintain their validated state to support Operations Schedule Adherence requirements. Partner with Quality to ensure Change Controls, Deviations, and CAPAs are closed on time with rigor and velocity. Design, create, and deliver training to Digital Sites that drives compliance of Data Integrity, Computer Systems Assurance, and traditional CSV. Support internal and external audits of digital systems to verify that systems are validated and maintained in a validated state in accordance with regulations and Resilience standards. Manage various aspects of digital systems to ensure the operational phase is in a state of compliance. Support requalification activities for validated in use manufacturing systems such as automated material handling systems, serialization, historians and ERP systems. Aid in Change Control development and strategy as well as provide CSV impact assessments for the proposed digital change requests. Develop and execute Data Migration Plans as required for digital system migrations. Provide guidance for other site departments on CSV processes and electronic validation lifecycle management tool. Minimum Qualifications: Extensive experience in federally regulated industries or CSV teams in Pharmaceutical / Biotech industry with comprehensive expertise and working knowledge of GxP, 21 CFR Parts 11, and Annex 11 compliance requirements, in implementing and maintaining GXP computer systems in a validated state. Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles, Agile development, and deployment approaches. Fluid collaboration skills across business, Digital, and external vendors/suppliers. Enhanced technical writing skills with attention to detail along with exc
RESILIENCE US INCKohl's CDC Support TeacherAbout the RoleAs an Early Childhood Support Teacher, you will provide daily care to children of all ages throughout the center, as outlined on your daily schedule. You will collaborate with primary and support teachers to execute classroom duties...
...MultiCare Health System is seeking a Radiology Technologist for a job in Covington, Washington. Job Description & Requirements ~... ...~ Guaranteed Hours ~403b retirement plan ~ Sick pay ~ Employee assistance programs ~ Dental benefits ~ Life insurance...
...soon in Salem, il Mercato at the Lake ! Discover a European-style market offering a variety of chef-crafted meals, select wines, and... ...responsible for taking orders using handheld technology, serving food and drinks in a timely accurate manner, as well as delivering a...
...paperwork for you. Maintain a flexible schedule by deciding how many clients you see through Headway, so that you can set the hours that work for you. Grow your caseload by providing marketing support and patient referrals. Well also support your patients by...
...Job Description SHIFT YOUR FUTURE Casual Package Deliver Driver SHIFT YOUR TEAM Who exactly are casual UPS Package Delivery Drivers? Theyre the ones who drive our familiar brown trucks, bringing packages great and small to our customers. Theyre a friendly...