Principal Engineer - Pharma Recipe Authoring

Job Description

REQUIREMENTS

• Total experience 11+ years in Pharma Manufacturing / MES consulting
• Hands-on experience with Pharma MES platforms such as Rockwell PharmaSuite, Siemens Pharma OpCenter, Werum PAS-X, or Tulip
• Strong experience in Pharma Recipe Authoring and MBR/EBR/EMBR configuration and execution
• Experience leading end-to-end MES implementations across Assessment, Design, Build, Integration, Validation, and Rollout phases
• Strong understanding of GxP compliance, data integrity, audit trails, electronic signatures, and validation requirements
• Experience with shopfloor system integration across ISA-95 layers (L1–L5) including automation, historians, and enterprise systems
• Knowledge of ISA-95 and ISA-88 standards for manufacturing operations and recipe management
• Experience working with multiple MES platforms with a platform-agnostic consulting mindset
• Familiarity with manufacturing analytics platforms, historians, data lakes, or event streaming architectures
• Experience working with global pharma manufacturing sites, multi-language deployments, and change management initiatives
• Strong communication, collaboration, and stakeholder management skills across Operations, QA, IT, Automation, and Validation teams
• Strong solutioning and pre-sales experience including customer workshops, opportunity shaping, and value articulation
• Ability to translate business requirements into system design and technical solution architecture

RESPONSIBILITIES

• Lead end-to-end MES implementation programs for pharmaceutical manufacturing environments
• Conduct discovery workshops to identify business problems, define value cases, and shape MES opportunities
• Drive process mapping (As-Is / To-Be), gap assessments, and requirements documentation (URS / FRS)
• Design and configure Recipe Management, MBR/EBR workflows, exception handling, and Review-by-Exception processes
• Architect and guide integration between MES, automation systems, ERP, LIMS, and other enterprise systems across L1–L5 layers
• Lead cross-functional teams across functional design, system integration, validation, and deployment
• Manage project scope, risks, milestones, and stakeholder communication across global programs
• Ensure regulatory compliance alignment including GxP, audit trails, and electronic records/signatures
• Support validation deliverables including documentation, testing coordination, and regulatory readiness
• Provide solution leadership during pre-sales engagements including demonstrations, workshops, and proposal development
• Influence customer decisions through value-based solutioning and risk-aligned architectural recommendations
• Support global rollouts, hypercare support, and continuous improvement initiatives post-implementation

Qualifications

Bachelor’s or master’s degree in computer science, Information Technology, or a related fields

Additional Information