Principal Loftware Solutions Architect

Lead the end?to?end migration to Loftware Spectrum and related enterprise labeling solutions, own the technical strategy for the implementation, set up a high?performing delivery pod, architect integration and validation in regulated environments, and implement a scalable, automated "migration factory" that reduces cost, accelerates time?to?value, and ensures sustained compliance and print performance.

Roles and Responsibilities:

• Design and lead the implementation of Loftware Spectrum and related enterprise labeling platforms (cloud or on?prem).
• Define overall architecture including HA/DR, security, performance, and scalability.
• Oversee installation, configuration, deployment, and administration of labeling environments.
• Lead end?to?end label template migration, including template conversion, artwork import, and format standardization.
• Perform impact analysis and label template gap assessments.
• Establish automated or semi?automated processes for template and data migration.
• Architect integrations between labeling systems and ERP, MES, PLM, QMS using REST/SOAP APIs.
• Develop or guide development using Java/JavaScript, ECMAScript, JSON/XML, and SQL.
• Define data mapping, ETL workflows, and error handling strategies.
• Implement and maintain compliance with 21 CFR Part 11, ISO 13485, EU MDR, and UDI (GS1/HIBCC) standards.
• Lead validation activities following GAMP 5/CSV: URS, FS/DS, IQ/OQ/PQ, risk assessments, and traceability.
• Author SOPs, work instructions, and change control documentation.
• Manage printer configurations, drivers, queues, and print?related troubleshooting.
• Establish print performance standards and monitoring mechanisms.
• Build and guide a small cross?functional labeling team.
• Coordinate with business, quality, and technical stakeholders.
• Create reusable frameworks, accelerators, and best practices for labeling operations.

• 10-15+ years in enterprise solution delivery.
• 7+ years in enterprise labeling platforms.
• 5+ years hands?on with Loftware Spectrum (with Spectrum architectural experience).
• Strong experience with cloud (preferably AWS) and on?prem infrastructure.
• Proven experience in regulated industries (medical devices, pharma, life sciences).
• Strong expertise in integrations with ERP/MES/PLM/QMS systems.
• Hands?on validation experience under CSV/GAMP 5.
• Demonstrated experience leading cross?functional teams and complex migrations.

Skills:

Must Have:

• Loftware Spectrum deep expertise (architecture, configuration, deployment, administration).
• Strong hands?on knowledge of label template design, migration, and artwork management.
• Experience with Java/JavaScript, REST/SOAP APIs, JSON/XML, and SQL databases (Postgres/Oracle/MSSQL).
• Integrations with ERP (e.g., SAP), MES, PLM, QMS.
• Solid understanding of SSO (SAML/OAuth), RBAC, audit trails.
• Regulatory and compliance experience:
• 21 CFR Part 11, ISO 13485, EU MDR, UDI/GS1/HIBCC.
• GxP validation experience (URS/FS/DS, IQ/OQ/PQ).
• Strong print infrastructure knowledge (Zebra/SATO, drivers, queues, spoolers).
• Ability to lead teams and work with cross?functional stakeholders.

Good to Have:

• Experience with Loftware LPS, Prisym 360, or Prisym R3.
• Exposure to Loftware Smartflow or artwork management systems.
• Knowledge of printer scripting languages (e.g., ZPL).
• Cloud certifications (e.g., AWS Architect).
• Project management certifications (PMP, Prince2, SAFe).
• Experience building automation utilities for template/data migration.
• Familiarity with DevOps tools (Jenkins, Azure DevOps) and Atlassian tools (Jira/Confluence).

The expected salary range for this position is between $63,000 to $1,20,000 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.