Kindeva Drug Delivery
Principal, Solution & Enterprise Architect I
Kindeva Drug Delivery, Saint Paul, Minnesota, United States, 55130
Overview
Principal, Solution & Enterprise Architect I
role at Kindeva Drug Delivery. The Lead architect for enterprise technology solutions across the global CDMO organization, designing and implementing scalable, secure, and compliant architectures across cloud-based and SaaS enterprise applications (ERP, MES, EBR, LIMS, PLM, CMMS). The ideal candidate will bring deep architectural experience, industry knowledge, and a passion for enabling digital transformation and Industry 4.0 initiatives. Collaboration with sites, IT, and Kindeva leadership is required to develop strategic roadmap initiatives and lead their delivery execution. The Solution Architect will drive innovation, digital transformation, and efficiency improvements through system enabling processes. Key Responsibilities
Development of strong stakeholder partnerships throughout the Kindeva network. Collaborate with partners to develop IT Application roadmaps. Support the prioritization and justification of programs/projects within manufacturing, logistics, and supply chain domains. Act as the liaison between business stakeholders and IT, designing and delivering prioritized projects. Be a key member of the Kindeva AI Advisory Board promoting the expansion and oversight of AI initiatives. Mentor KDD ERP application analysts and expand knowledge of D365 capabilities. Partner with manufacturing sites to integrate OT and IT systems. Lead technical design efforts across global programs including ERP, MES, EBR, and smart manufacturing systems. Collaborate with business process owners, project teams, and IT leadership to translate requirements into sustainable technical solutions. Drive architecture for Industry 4.0 initiatives including IoT, real-time data platforms, and unified namespace strategies. Ensure compliance with data integrity, security, and regulatory standards including GxP, 21 CFR Part 11, Annex 11, and CSV. Innovate and identify opportunities for improvement by staying informed on emerging enterprise application technologies. Required Qualifications
Technical & Functional Expertise: Deep knowledge of enterprise application systems (ERP, Manufacturing, Quality, and other business-critical applications). Experience in the pharmaceutical or biotechnology industries, including regulatory requirements (FDA/EMA) and GMP. Experience in data management and analytics to optimize supply chain and manufacturing processes. Strong manufacturing and warehousing expertise and process/solution design. Bachelors degree in Computer Science, Engineering, Information Systems, or related field. 7+ years of experience in enterprise or solution architecture roles, preferably within pharmaceutical or regulated manufacturing environments. Demonstrated expertise in cloud-native and hybrid IT architectures. Strong knowledge of D365 ERP, MES, LIMS, PLM, and manufacturing data systems. Experience with integration technologies and protocols (REST APIs, ESB, OPC UA, MQTT). Deep understanding of GxP, data integrity, and computer systems validation (CSV). Preferred Credentials
D365 ERP Advanced Warehousing, Inventory Management, and Supply Chain Management. OT systems supporting data collection and analytics (e.g., OEE KPI). GAMP 5 compliance standards. Hands-on experience with Industry 4.0 technologies and smart factory deployments. Success Factors
Strategic mindset balancing technical depth and business acumen. Strong cross-functional communication and stakeholder engagement skills. Ability to work independently and lead architectural decisions with minimal oversight. Passion for innovation and continuous improvement. Notice
California residents should review our Notice for California Employees and Applicants before applying. Equal Opportunity Employer
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, protected veteran status, sexual orientation, or any other characteristic protected by federal, state, or local law. Do you see yourself as part of the Kindeva mission? Click Apply Now Today! #J-18808-Ljbffr
Principal, Solution & Enterprise Architect I
role at Kindeva Drug Delivery. The Lead architect for enterprise technology solutions across the global CDMO organization, designing and implementing scalable, secure, and compliant architectures across cloud-based and SaaS enterprise applications (ERP, MES, EBR, LIMS, PLM, CMMS). The ideal candidate will bring deep architectural experience, industry knowledge, and a passion for enabling digital transformation and Industry 4.0 initiatives. Collaboration with sites, IT, and Kindeva leadership is required to develop strategic roadmap initiatives and lead their delivery execution. The Solution Architect will drive innovation, digital transformation, and efficiency improvements through system enabling processes. Key Responsibilities
Development of strong stakeholder partnerships throughout the Kindeva network. Collaborate with partners to develop IT Application roadmaps. Support the prioritization and justification of programs/projects within manufacturing, logistics, and supply chain domains. Act as the liaison between business stakeholders and IT, designing and delivering prioritized projects. Be a key member of the Kindeva AI Advisory Board promoting the expansion and oversight of AI initiatives. Mentor KDD ERP application analysts and expand knowledge of D365 capabilities. Partner with manufacturing sites to integrate OT and IT systems. Lead technical design efforts across global programs including ERP, MES, EBR, and smart manufacturing systems. Collaborate with business process owners, project teams, and IT leadership to translate requirements into sustainable technical solutions. Drive architecture for Industry 4.0 initiatives including IoT, real-time data platforms, and unified namespace strategies. Ensure compliance with data integrity, security, and regulatory standards including GxP, 21 CFR Part 11, Annex 11, and CSV. Innovate and identify opportunities for improvement by staying informed on emerging enterprise application technologies. Required Qualifications
Technical & Functional Expertise: Deep knowledge of enterprise application systems (ERP, Manufacturing, Quality, and other business-critical applications). Experience in the pharmaceutical or biotechnology industries, including regulatory requirements (FDA/EMA) and GMP. Experience in data management and analytics to optimize supply chain and manufacturing processes. Strong manufacturing and warehousing expertise and process/solution design. Bachelors degree in Computer Science, Engineering, Information Systems, or related field. 7+ years of experience in enterprise or solution architecture roles, preferably within pharmaceutical or regulated manufacturing environments. Demonstrated expertise in cloud-native and hybrid IT architectures. Strong knowledge of D365 ERP, MES, LIMS, PLM, and manufacturing data systems. Experience with integration technologies and protocols (REST APIs, ESB, OPC UA, MQTT). Deep understanding of GxP, data integrity, and computer systems validation (CSV). Preferred Credentials
D365 ERP Advanced Warehousing, Inventory Management, and Supply Chain Management. OT systems supporting data collection and analytics (e.g., OEE KPI). GAMP 5 compliance standards. Hands-on experience with Industry 4.0 technologies and smart factory deployments. Success Factors
Strategic mindset balancing technical depth and business acumen. Strong cross-functional communication and stakeholder engagement skills. Ability to work independently and lead architectural decisions with minimal oversight. Passion for innovation and continuous improvement. Notice
California residents should review our Notice for California Employees and Applicants before applying. Equal Opportunity Employer
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, protected veteran status, sexual orientation, or any other characteristic protected by federal, state, or local law. Do you see yourself as part of the Kindeva mission? Click Apply Now Today! #J-18808-Ljbffr