Engineering Specialist, Laboratory Digital Transformation

About Ardena

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.

The Ardena Group operates from five sites across Europe and the United States, employing more than 750 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena US facility is based in Somerset, New Jersey.

Ardena provides integrated services spanning drug substance development, drug product formulation, GMP manufacturing, bioanalytical services, clinical logistics, fill and finish, and CMC regulatory support.

Position: Engineering Specialist, Laboratory Digital Transformation

Department: Engineering

Location: Somerset (US)

Ardena is hiring an Engineering Specialist, Laboratory Digital Transformation to join the Engineering team at our Somerset, NJ site. This role supports pharmaceutical development and manufacturing activities within a GMP-regulated environment.

The Engineering Specialist, Laboratory Digital Transformation Specialist is a hands‑on, lab‑floor role that implements and sustains digital tools to increase efficiency, throughput, and data integrity in QC/Analytical laboratories. Reporting to the Engineering Director with a dotted line to QC, this specialist supports the Digital 4.0 Program Manager by executing configuration, testing, training, and day‑to‑day support—primarily in Sapio LIMS—so lab teams can do more with Sapio: streamline workflows, reduce manual steps, and turn data into action.

This position does not own enterprise digital strategy or architecture.

• Configure Sapio LIMS objects (fields, forms, templates, picklists, vocabularies) and workflows for sample lifecycle, test methods, stability, and result management under the direction of system owners and the Digital 4.0 Program Manager.
• Execute UAT (test scripts, defect capture, re‑tests), document changes, and elevate issues to IT/Validation as needed.
• Optimize Sapio usage (batch actions, dashboards, triggers/automations, RBx where applicable) to reduce clicks, shorten cycle time, and improve right‑first‑time data entry.
• Partner with analysts and supervisors to map current lab workflows, identify bottlenecks, and digitize manual steps (sample logging, assignment, results entry, review‑by‑exception, approvals).
• Build simple dashboards and operational views (e.g., sample queues, TAT, priority boards) that improve scheduling, workload balance, and visibility.
• Translate operator feedback into actionable LIMS adjustments that enhance usability and throughput without compromising compliance.
• Assist with sustaining data flows between Sapio and lab instruments/systems (e.g., Empower exports, LabX, balances, file‑based imports) by coordinating mappings, folder structures, and permissions with IT/Validation.
• Support basic troubleshooting of import rules, parsing, and structured results; elevate complex issues to system owners or vendors.
• Support CSV/CSA deliverables for LIMS changes (URS inputs, risk assessments, test evidence, traceability, training records) following ISPE GAMP 5 principles.
• Ensure configurations meet 21 CFR Part 11, EU Annex 11, and ALCOA+ expectations; maintain clean metadata and controlled vocabularies.
• Deliver targeted training (1:1 and small groups), create job aids/quick‑reference guides, and provide on‑bench support during go‑lives and minor releases.
• Act as a lab‑floor ambassador for digital adoption—reinforcing standard work and best practices to sustain gains.
• Work daily with QC, Analytical Development, IT, Validation, Engineering, and the Digital 4.0 Program Manager to align configurations with operational needs and release calendars.
• Participate in CI activities (Lean/Six Sigma tools) targeting reduction of handoffs, cycle time, and documentation errors.

• Bachelor’s degree in Chemistry, Biology, Engineering, Computer Science, or related field; or…