Digital Thread Engineer - Pharmaceutical Lifecycle

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Location: [Global/ Remote / Hybrid]

Department: Digital Product Lifecycle Team

Company Overview

Pangaea Life Science Solutions Ltd specializes in delivering cutting-edge digitisation software and solutions for the biopharmaceutical sector, specifically focused on the lifecycle of pharmaceutical products from late phase research to commercialization. Our products are designed to optimize R&D, manufacturing, and supply chain processes. Key products include the Digital Thread for Life Science™ (PLM), SiMPL™ (MES), and Batch Disposition Cockpit.

In addition to our innovative products, we offer comprehensive consultancy and services. Our expertise spans the business domain of development, technology transfer & commercialisation, system landscape design, program and project planning, and implementation.

Headquartered in Ireland, with additional offices in the United States, Canada and the UK, we proudly serve global pharmaceutical corporations, driving efficiency and innovation across the industry.

Position Summary

We are seeking a visionary and technically skilled Digital Thread Engineer to play a pivotal role in architecting and implementing our end-to-end digital thread strategy. In this role, you will be the key technical expert responsible for creating a seamless, integrated flow of data across the entire product lifecycle, from R&D and process development to commercial manufacturing and distribution.

You will bridge the gap between IT, engineering, data science, and quality functions to build a connected data backbone that enables real-time process understanding, advanced analytics, and data-driven decision-making, ultimately ensuring product quality and supply chain resilience.

Key Responsibilities

· Strategy & Architecture:

o Design, develop, and implement the architecture for the digital thread, ensuring it connects systems like MES (Manufacturing Execution System), ERP (SAP), LIMS (Laboratory Information Management System), PLM, SCADA, and QMS.

o Define data models, ontologies, and interoperability standards to ensure consistent and meaningful data flow across disparate sources.

o Evaluate and select appropriate technologies (e.g., IoT platforms, cloud services - AWS/Azure, data lakes) to support the digital thread.

· Implementation & Integration:

o Lead the technical integration of systems and data sources to create a unified view of the product and process.

o Develop and deploy data pipelines for the ingestion, transformation, and contextualization of product, process, development, regulatory, manufacturing and quality data.

o Collaborate with business and digital teams to enable seamless data acquisition from shop-floor equipment and sensors.

· Data Governance & Lifecycle Management:

o Establish and enforce data governance policies, ensuring data integrity, security, and compliance with 21 CFR Part 11, Annex 11, and GxP regulations.

o Manage the lifecycle of digital thread assets, including data models, interfaces, and integration points.

· Cross-Functional Collaboration & Use Case Development:

o Partner with business stakeholders in Process Development, Manufacturing, Quality, and Supply Chain to identify and prioritize high-value use cases for the digital thread (e.g. real-time release testing, root cause analysis, process optimization).

o Translate business requirements into technical specifications and functional digital thread solutions.

· Innovation & Continuous Improvement:

o Stay current with emerging technologies in Industry 4.0, IIoT, AI/ML, and digital twins.

o Champion a culture of data-driven continuous improvement and digital innovation within the organization.

Qualifications & Experience

Required:

· Bachelor’s or Master’s degree in Computer Science, Engineering, Data Science, Chemical Engineering, or a related field.

· 5+ years of experience in a role involving data integration, systems architecture, or digital transformation, preferably within the pharmaceutical, biotech, or medical device industry.

· Proven experience with GxP systems and a strong understanding of 21 CFR Part 11 and data integrity ALCOA+ principles.

· Hands-on technical expertise with:

o Manufacturing systems: MES (e.g., Werum, PAS-X), LIMS, SCADA/HMI, ERP (S.g., SAP S/4HANA).

o Data Engineering: SQL, Python, PySpark, or similar languages for building data pipelines.

o Integration Platforms: OSIsoft PI System, MuleSoft, or similar IoT/IIoT platforms.

o Cloud Platforms: AWS, Azure, or Google Cloud Platform and their data services (e.g., AWS IoT Core, Azure IoT Hub, Data Bricks, Snowflake).

Preferred:

· Deep knowledge of SAP

· Experience with semantic modeling and ontologies (e.g., OPC UA).

· Familiarity with Digital Twin concepts and Advanced Process Control (APC).

· Knowledge of process modeling and simulation tools.

· Understanding of pharmaceutical unit operations and process development.

· Excellent project management, communication, and stakeholder management skills.

Competencies

· Strategic Thinker: Ability to see the big picture and translate it into a practical, phased implementation plan.

· Problem Solver: Adept at troubleshooting complex technical and data integration challenges.

Collaborative Bridge-Builder: Excels at working in cross-functional teams with both technical and non-technical stakeholders.

Detail-Oriented: Meticulous attention to detail, especially concerning data quality and regulatory compliance.

Innovative Mindset: Passionate about leveraging technology to solve real-world business problems.

What We Offer

· A competitive salary and comprehensive benefits package.

· The opportunity to work on cutting-edge digital projects that have a direct impact on patient lives.

· A collaborative and supportive work environment with opportunities for professional growth.

· Exposure to senior leadership and a chance to shape the digital future of a leading pharmaceutical company.

· A culture of trust and autonomy that values results over hours, supporting personal flexibility and a healthy work-life balance.

Job Types: Full-time, Permanent

Pay: €29,593.17-€72,196.74 per year

Benefits:

• Flexitime
• On-site parking
• Work from home

Work authorisation:

• Ireland (preferred)

Work Location: Hybrid remote in Blackrock Cork, CO. Cork