Job Description
DescriptionWe are seeking a Solutions Architect that will serve as a Kneat strategic advisor technologist and evangelist to our customers, bringing deep expertise in validation software, software development systems, ERP systems, QMS, CSV, AI and integrations across a multi-IT platform. This role is critical for designing and implementing innovative, compliant solutions that support our Pharma 4.0 initiatives and drive operational excellence.Why join Kneat’s Global Operations team?Joining the Global Operations team is an opportunity to accelerate your career. We’re a world class team which enable organisations in the regulated space to move to an intelligent fully digitised solution. Our product, Kneat GX, is the world’s most advanced validation software to help revolutionise the speed, precision, transparency, and intelligence of validation in the Life Sciences sector. Our solution is now used by the majority of the world’s leading Life Sciences companies.What you’ll doWe are seeking a dynamic and customer facing Solutions Architect to join our team and support our operations department. This role is the Subject Matter Expert with respect to Kneat and IT Platforms.Strategic Advisory and Solution Design: Act as a strategic advisor to customer platforms, providing expert guidance on leveraging AI, Jira, ERP as well as other enterprise systems and how to extract the value out of Kneat GX.Develop and design comprehensive solutions that align with Pharma 4.0 principles and meet business requirements.Create detailed technical specifications and documentation for proposed solutions.AI and Machine Learning Integration: Identify and implement AI-driven solutions to enhance business processes, data analytics, and decision-making.Design in conjunction with customers their AI integration strategies that optimize operational efficiency and product quality.System Integrations: Lead the integration of various enterprise systems to ensure seamless data flow and interoperability.Develop and manage integration strategies that support real-time data exchange and process automation.Support onsite Customer workshops on mapping out their IT landscape to include all their Kneat GX and other Quality systems.Validation and Compliance: Ensure all solutions adhere to pharmaceutical industry regulations and validation requirements.Develop and implement comprehensive validation plans, protocols, and reports to maintain compliance with GxP standards.Collaborate with quality assurance and regulatory teams to ensure systems are audit-ready and compliant with all regulatory requirements.Support the communication of our Product Roadmap to the Customer’s IT stakeholders including CSV, Integrations etc.Cross-Functional Collaboration: Lead cross-functional teams to deliver complex solution architecture projects on time and within budget.Collaborate with stakeholders, including IT, quality assurance, regulatory, and business units, to ensure alignment and successful implementation of solutions for the customer.RequirementsBachelor’s or Master’s degree in Computer Science, Information Technology, Engineering, or a related field.Proven experience as a Solutions Architect in the pharmaceutical industry or a similar regulated environment.Expertise in AI and machine learning applications, with a strong understanding of their integration into business processes.Extensive experience with SAP and Jira, including integrations and project management.In-depth knowledge of pharmaceutical validation processes and regulatory compliance (GxP, FDA, EMA).Strong understanding of document management systems and best practices in a regulated environment.Proven experience in computer system validation (CSV).Excellent project management skills with the ability to lead and collaborate with cross-functional teams.Strong analytical, problem-solving, and communication skills.Relevant certifications in AWS, Azure, Jira, SAP, AI, are a plus.What we offer youAt Kneat, we truly value ideas and collaboration so we’ve created an environment that builds, protects, and celebrates teamwork. Our strong culture is central to our continued success.We offer programs and rewards that one would expect from a highly successful and growing technology company.A fantastic culture, team, and energy. Competitive compensation. Comprehensive benefits package. Flexible work arrangements. Training and professional development.Kneat is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to Equal Employment Opportunity (EEO) regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.Reasonable accommodations may be made to enable qualified individuals with disabilities or special needs to perform these essential functions. If you have a disability or special need that requires accommodation to complete this application form, please contact us at +353 (0)612 038 26 (Ext 2004) or email us at hr@kneat.com for assistance. #J-18808-Ljbffr