PASX Architect at American Unit, Inc

JD: • Senior-level experience designing and delivering Werum PAS X MES architectures for pharmaceutical/biotech manufacturing, including multi-site and global deployments

• Deep knowledge of MES concepts and standards (ISA 88, ISA 95) and how they translate into PAS X solution patterns, data models, and production templates.

• Responsibility for end-to-end solution architecture: logical & physical design, scalability, high availability, disaster recovery, capacity planning, and performance tuning.

• Lead integration strategy and design for peripheral systems (SAP, LIMS, ERP, PLC/SCADA, historians) using appropriate interface patterns (IDoc/XML/REST/OPC/web services) and middleware.

• Define validation approach and ensure architecture supports GMP, CSV, electronic signatures, audit trails, and 21 CFR Part 11 / Annex 11 compliance requirements.

• Strong expertise with infrastructure platforms (on prem and cloud), network/security considerations, Windows/SQL Server stacks, and deployment automation options.

• Establish governance, standards, and reusable reference architectures for PAS X configuration, release management, environment promotion, and configuration drift control.

• Create and review technical design documents, integration specifications, security designs, and validation deliverables; provide technical leadership in design reviews.

• Mentor and coordinate cross-functional teams (configuration engineers, QA, IT, automation engineers) and act as technical liaison with vendor(s) and stakeholders.

• Lead risk assessments, non functional requirements definition, cutover/rollout planning, and provide post go live architecture support and optimization

• Proficiency with relational databases (Microsoft SQL Server), writing and debugging SQL queries, and supporting application-level data flows.

• Scripting or development skills for configuration tasks and automation (e.g., C#, .NET, JavaScript, or Python) and familiarity with version control tools.

• Experience producing technical documentation: design specs, configuration guides, validation deliverables, SOPs, and change control records

• Excellent communication skills, ability to work with cross-functional teams (TQ / EQ, Production, IT), and willingness to travel for commissioning/support as required.

Preferred / Nice-to-have:

• Experience with Azure cloud providers, containerization, CI/CD for MES deployments, and infrastructure-as-code practices.

• Prior role as PAS X solution architect on full lifecycle implementations across multiple sites.

• Certifications in PAS X and formal training in GMP/CSV.

• Strong background in data migration strategies, analytics/OT data modeling, and MES operational reporting

Top Skills:

- 10+ years of strong experience in PAS-X Architect experience

- Pharmaceutical Process Knowledge & GxP Compliance

- Technical Integration & Data Systems