Job Responsibilities

Requirements & Analysis

Engage Business SMEs and Key Users to elicit, analyse, and document functional and technical requirements
Author User Requirement Specifications (URS) and Functional Requirement Specifications (FRS)
Map common processes across manufacturing sites to enable Global PI design

Solution Design & Configuration

Design site-specific and global Process Instructions (PIs) aligned to GMP requirements
Configure Opcenter Execution Pharma / Simatic IT eBR modules end-to-end
Collaborate with MES engineers on integration design with ERP, LIMS, and DCS/SCADA systems

Validation & Quality

Lead validation activities in compliance with GxP, 21 CFR Part 11, and EU Annex 11
Develop IQ/OQ/PQ test scripts, Design Specifications, and Traceability Matrices
Support defect resolution and change management throughout delivery

Documentation

Maintain comprehensive documentation: URS, FRS, Design Specs, Test Scripts, and SOPs
Ensure all artefacts meet internal quality standards and client requirements

Team Leadership & Stakeholder Management

Job Requirements

Experience (Essential)

Minimum 5 years of hands-on MES implementation experience, with strong expertise in Siemens Opcenter Execution Pharma (Simatic IT eBR) or equivalent pharma MES platform
Proven delivery track record in pharmaceutical, biotech, or life sciences projects
Solid exposure to GxP-regulated environments; working knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5
Demonstrated ability to gather requirements and author functional specifications
Experience leading or mentoring team members in a project setting

Technical Skills

Strong proficiency in Opcenter Execution Pharma / Simatic IT eBR configuration and PI design
Good understanding of MES integration patterns (ERP, LIMS, DCS/SCADA, historians)
Familiarity with batch manufacturing, dispensing, packaging, and QC workflows
Competency in validation methodology and documentation standards
Working knowledge of SQL or data query tools is advantageous

Competencies

Analytical mindset with structured problem-solving approach
Excellent communication skills — effective with both technical and business audiences
High attention to detail and commitment to quality outcomes
Self-motivated; thrives independently and in collaborative team settings

Qualifications

Siemens Opcenter Execution Pharma (Simatic IT eBR) - Techno-Functional Consultant