Principal Engineer,Pharma Recipe Authoring

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

Department: Engineering
Function: Information Technology
Experience Level: Not Applicable