Digital Systems Support Specialist (Manufacturing & SAP Integration)
Location : Westborough, MA (Onsite)
Duration : 06 Month+
About the Role:
Client is seeking a high-caliber Digital Systems Support Specialist to spearhead a critical, high-visibility digital transformation initiative. This role is designed for a technical visionary who thrives at the intersection of biopharmaceutical manufacturing operations and complex enterprise systems.As the primary architect and coordinator for the integration of Apprentice Tempo (Electronic Batch Records) with SAP, you will be responsible for engineering a seamless data flow that accelerates our digital maturity, enhances operational efficiency, and maintains the highest standards of data integrity.
Key Responsibilities:
Integration Strategy & Leadership: Lead the end-to-end design, rigorous testing, and phased implementation of the integration between Apprentice Tempo eBR and SAP.
System Architecture: Define sophisticated data mapping and interface requirements to establish a "single source of truth" across manufacturing execution (MES) and ERP platforms.
Cross-Functional Orchestration: Serve as the strategic liaison between Manufacturing Operations, IT, Quality Assurance, and Supply Chain to align digital workflows with real-time production demands.
Digital Roadmap Development: Drive the site’s digital evolution by identifying opportunities to automate data capture, eliminate manual reconciliation, and drastically streamline batch release cycles.
Advanced Troubleshooting: Act as the Tier 1–3 Subject Matter Expert (SME) for complex system conflicts, ensuring maximum uptime within a fast-paced cGMP manufacturing environment.
Required Qualifications & Experience:
Educational Foundation: Bachelor’s degree in Biological Sciences, Engineering, Chemistry, or a related technical field; alternatively, 6–10 years of equivalent experience in Biopharma Manufacturing or Manufacturing Execution Systems (MES).
SAP Integration Expertise: A proven track record of successfully integrating Electronic Batch Records (eBR) or MES platforms with SAP (or similar Tier-1 ERP systems).
Technical Fluency: Deep understanding of data flow protocols, API integrations, and the stringent validation requirements (GxP) inherent in life sciences digital systems.
Project Governance: Demonstrated ability to lead high-visibility initiatives, manage complex timelines, and translate technical jargon into actionable insights for non-technical stakeholders.
Regulatory Knowledge: Strong command of cGMP, 21 CFR Part 11, GxP validation, and data integrity principles.
Preferred Qualifications:
Apprentice Tempo Proficiency: Expert-level, hands-on experience with the Apprentice Tempo platform is highly advantageous.
Specialized Experience: Background in Gene Therapy or high-growth biopharmaceutical settings.
System Familiarity: Prior experience with Labware LIMS, BMRAM, or equipment integration workflows.
Process Improvement: Experience supporting manufacturing digitalization and Lean process optimization.