| Location | Somerset, New Jersey |
| Website | https://careers.ardena.com |
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.
For the Ardena Business Unit based in Somerset (US), we are looking for a Engineering Specialist, Laboratory Digital Transformation.
Ardena provides integrated services spanning drug substance development, drug product formulation, GMP manufacturing, bioanalytical services, clinical logistics, fill and finish, and CMC regulatory support.
Job Overview
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.
Role Description
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.
Key Responsibilities
Sapio LIMS Support & Configuration (Primary Focus)
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 escalate 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.
Lab Workflow Efficiency & Productivity Enablement
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.
Instrument & System Connectivity (Support Role)
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; escalate complex issues to system owners or vendors.
Compliance, Data Integrity & CSV Support
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.
Training, Adoption & Floor Support
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.
Cross‑Functional Collaboration
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.
Profile & Qualifications
Education and Experience:
Bachelor’s degree in Chemistry, Biology, Engineering, Computer Science, or related field; or equivalent lab systems support experience.
3–5 years of experience supporting LIMS or digital laboratory systems in GMP/GLP environments; Sapio LIMS hands‑on configuration strongly preferred.
Knowledge/Skills:
Practical knowledge of LIMS configuration, method/test setup, sample lifecycle workflows, and structured data design.
Familiarity with QC lab operations (sample management, stability, Empower‑based data flows, balances/LabX) and basic interface troubleshooting (support level).
Working understanding of 21 CFR Part 11, Annex 11, Data Integrity (ALCOA+), and ISPE GAMP 5 lifecycle concepts; able to execute CSV tasks under guidance.
Strong problem‑solving, documentation, and communication skills; able to translate analyst feedback into scalable LIMS improvements.
CI mindset (Lean/Six Sigma tools) to sustain measurable productivity gains.
Alignment with Ardena’s CARE values: Communicative, Accountable, Reliable, and Excellent
Physical Requirements:
Frequent presence in QC/AD lab spaces; ability to stand/walk for extended periods and move between benches, instrument rooms, and offices.
Ability to wear required PPE (lab coat, safety glasses, gloves); fine motor dexterity for terminals, peripherals, and small components.
Work Environment/Safety Conditions:
Fast‑paced, priority‑driven lab environment requiring strict adherence to GMP, data integrity, and lab safety procedures; occasional after‑hours support for LIMS updates or troubleshooting.
Routine work around analytical instruments and controlled environments with frequent collaboration across QC, AD, IT, Validation, and Engineering.
Fast‑paced, priority‑driven environment with frequent collaboration across Operations, Engineering, IT, QA, QC, and Validation; occasional off‑hours support for go‑lives or production‑critical activities.
What Ardena Offers
Ardena is a science-driven and people-focused employer. Working at Ardena means contributing to pharmaceutical projects that support the availability, safety, and quality of medicines for patients worldwide.
Ardena offers an international working environment where employees are encouraged to develop their expertise, take ownership, and grow their careers across functions and locations.
Benefits and perks at Ardena include:
• Competitive salary and tailored benefits package (adjusted per role and location)
• Flexible working arrangements and paid annual leave (where applicable, depending on role and site)
• International and collaborative work environment across European and US sites
• Access to professional development and training programs
• Meaningful work on pharmaceutical development projects that advance patient health
• A values-driven culture guided by Ardena’s CARE principles: Communicative, Accountable, Reliable, and Excellent
The Salary Range for this role is $95,000.00 - $115.000.00
How to Apply
Ready to advance your career in pharmaceutical development? Apply now through the Ardena Careers website at careers.ardena.com.