Computer Systems Validation Engineer III
2 days ago
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 www.resilience.com 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
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Process Engineer III
1 week ago
Hamilton, United States RESILIENCE US INC Full timeA 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...
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Process Engineer III, MSAT
1 week ago
Hamilton, United States RESILIENCE US INC Full timeA 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...
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Hamilton, Ohio, United States RESILIENCE US INC Full timeA career at Resilience US INC is an opportunity to shape the future of biomanufacturing. Our company is dedicated to creating sustainable manufacturing solutions that withstand disruptions and serve scientific discovery. Job SummaryThe MSAT Process Engineer III plays a crucial role in executing technical aspects of product and process technology transfer to...
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Process Engineer III
1 week ago
Hamilton, United States RESILIENCE US INC Full timeA 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...
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Process Engineer III
1 week ago
Hamilton, United States RESILIENCE US INC Full timeA 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...
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Systems Specialist III
1 day ago
Hamilton, United States Albireo Energy Full timeThis position is responsible for assisting in the operation of the department. An individual in this position will be expected to perform additional job-related responsibilities and duties throughout the facility as assigned and or as necessary. In addition to the responsibilities below, the BAS Specialist III performs routine and complex technical duties in...
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Senior Security Engineer
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Hamilton, United States Keen Logic Full timeKeenLogic is seeking to hire a Senior Security Engineer to join our team at the Drug Enforcement Administration. The Senior Security Engineer supports one or more of the following cybersecurity related functions, information security, incident response, cybersecurity, user activity monitoring, computer forensics, Security Planning Assessment &Authorization...
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Senior Optical Systems Engineer
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Hamilton, United States SAIC Full timeDescription SAIC is seeking a highly experienced Optical Engineer to provide Systems Engineering services to a Government customer. The Optical Engineer will have a working understanding of optical networks and lab experience manipulating and maintaining optical equipment. You will also demonstrate a solid systems engineering background enabling development,...
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Advanced Vision Software Engineer
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Power Systems Electrical Engineer
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Process Engineer IV, MSAT
1 week ago
Hamilton, United States RESILIENCE US INC Full timeA 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...
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Automation Engineer
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Hamilton, United States Kelly Full timeJob DescriptionAutomation Engineer | Cincinnati, Ohio (West Chester)Direct Hire | On-site Kelly Engineering is seeking an Automation Engineer to join our clients' biomanufacturing team. Client is open to assisting with relocation expenses.In this role, you will lead and advise on projects across site departments, including Formulation, Aseptic Filling,...
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Principal Systems Engineer
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Hamilton, Virginia, United States Raytheon Technologies Full timePrincipal Systems EngineerAt Raytheon Technologies, we are seeking a Principal Systems Engineer to execute all aspects of systems engineering, including software design, build, integration, and test. The ideal candidate will possess strong proficiency in PHP, Ruby, or another web-focused object-oriented programming language.Key Responsibilities:Developing...
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Software Engineer
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Hamilton, United States Actalent Full timeJob Title: Software EngineerJob Description We are seeking two software engineers who have a passion for creating computer vision or AR/VR technologies to develop new situational awareness technology for military vehicles. This role involves collaborating with Ft Belvoir’s C5ISR (DEVCOM) Command to create innovative solutions using the latest in computer...
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HVAC Mechanical Engineer
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Hamilton, United States Liberty Personnel Services, Inc Full timeJob DescriptionJob DescriptionMy client is a well regarded MEP Consulting Engineering firm that is actively seeking multiple HVAC Mechanical Engineers in the mid-level to Senior level area. They are actively seeking Mechanical Engineers with 5+ years of Consulting Engineering experience.Looking for an Engineer who will be responsible for representing the...
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Vehicle Dynamics Engineer
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Hamilton, United States Krupp Bilstein of america, Inc Full timeCompany In the United States, BILSTEIN of America employs approximately 750 extremely focused, driven and passionate employees in four different locations: San Diego, CA, Mooresville, NC, Troy, MI and our only North American production and headquarters facility in Hamilton, OH. This 24/7 facility uses the newest technology to assemble the majority of our...
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Senior System Integration Analyst
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Software Development Engineer
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Hamilton, United States CV Library Full timeAmazon Web Services (AWS) is the world leader in providing a highly reliable, scalable, low-cost infrastructure platform in the cloud that powers hundreds of thousands of businesses in 190 countries around the world Passionate about building, owning and operating massively scalable systems? Experienced in building and leading teams of highly competent...
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Senior DevOps Engineer
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Hamilton, United States SAIC Full timeDescription We are seeking a highly skilled and experienced Senior DevOps Engineer with a strong focus on DevOps methodologies to join our IT team. The ideal candidate will be responsible for leading the integration of complex systems, automating workflows, and facilitating continuous integration and continuous deployment practices to enhance operational...
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Senior DevOps Engineer
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Hamilton, United States SAIC Full timeDescription We are seeking a highly skilled and experienced Senior DevOps Engineer with a strong focus on DevOps methodologies to join our IT team. The ideal candidate will be responsible for leading the integration of complex systems, automating workflows, and facilitating continuous integration and continuous deployment practices to enhance operational...