Engineering Specialist, Manufacturing 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.

Position:
Engineering Specialist, Manufacturing Digital Transformation
Department:
Engineering

Location:

Somerset (US)

Ardena is hiring an Engineering Specialist, Manufacturing 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 Digital Manufacturing Specialist is a hands‑on, on‑floor technical role that supports GMP Operations by implementing and sustaining digital manufacturing tools and workflows. Reporting to the Engineering Director and working closely with the Digital 4.0 Program Manager (program owner), this role executes configuration, testing, training, and day‑to‑day support for systems such as Master Control Manufacturing Excellence (Mx), OEE dashboards, and related shop‑floor applications.

The specialist partners with Operations, IT, QA, QC, Validation, and Engineering to ensure digital solutions are reliable, compliant, and operator‑friendly—without owning site strategy, architecture, or enterprise roadmaps.

• Serve as the boots‑on‑the‑ground point person on the manufacturing floor to support digital tools (e.g., MES/Mx e‑batch records, e‑logs, digital forms).
• Execute defined configuration tasks in Master Control Mx (templates, forms, workflows) under direction of the Digital 4.0 Program Manager and system owners.
• Perform UAT, draft/execute test scripts, capture defects and verify fixes; accelerate issues promptly.
• Provide day‑to‑day user support: triage tickets, troubleshoot basic issues, and coordinate with IT/Automation for resolution.
• Assist with system integrations across MES/Mx, QMS, LIMS, ERP, and automation data sources by gathering requirements, coordinating testing, and documenting results (no enterprise architecture ownership).
• Enable data capture for OEE, downtime categorization, and basic production analytics; develop or maintain frontline dashboards in collaboration with Operations and IT.
• Map current processes and help digitize paper‑based workflows; recommend configuration changes that simplify operator tasks and reduce errors.
• Support resource planning and asset utilization visibility (labor/equipment) through configured dashboards and reports.
• Participate in CI activities (Lean/Six Sigma tools) targeting throughput, changeover, and documentation accuracy improvements.
• Follow ISPE GAMP 5 and site procedures to support CSV/CSA deliverables (URS inputs, risk assessments, test evidence, traceability, training records).
• Ensure solutions meet 21 CFR Part 11, EU Annex 11, and data integrity expectations; maintain accurate configuration notes and change records.
• Create quick‑reference guides, SOP work‑aids, and floor‑ready training content; deliver small‑group training and refreshers.
• Support communications and user‑adoption activities led by the Digital 4.0 Program Manager.
• Partner daily with Operations, Supervisors, QA, QC, IT, Validation, and Engineering; communicate clearly in a production environment and elevate risks early.
• Coordinate planned go‑lives and minor releases to minimize production impact; occasional off‑hours support during implementations.

• Education and Experience: Bachelor’s degree in Engineering, Industrial/Manufacturing Systems, Computer Science, or related field; or equivalent practical experience in GMP manufacturing technology.
• Experience: 3–5 years in GMP manufacturing, digital systems, MES, or operations technology support (life sciences preferred).
• Technical
  
  Skills:
  
  Hands‑on…