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 an Engineering Specialist, Manufacturing 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, 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.
Role Description
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 MasterControl 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.
Key Responsibilities
Digital Support & Execution
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).
Perform UAT, draft/execute test scripts, capture defects, and verify fixes; escalate issues promptly.
Integrations & Data Enablement (Support Role)
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).
Operations & Continuous Improvement
Compliance, CSV Support & Documentation
Follow ISPE GAMP 5 and site procedures to support CSV/CSA deliverables (URS inputs, risk assessments, test evidence, traceability, training records).
Change Management & Training (Execution)
Cross‑Functional Collaboration
Partner daily with Operations, Supervisors, QA, QC, IT, Validation, and Engineering; communicate clearly in a production environment and escalate risks early.
Profile & Qualifications
Education and Experience:
Bachelor’s degree in Engineering, Industrial/Manufacturing Systems, Computer Science, or related field; or equivalent practical experience in GMP manufacturing technology.
3–5 years in GMP manufacturing, digital systems, MES, or operations technology support (life sciences preferred).
Working knowledge of GMP, 21 CFR Part 11, EU Annex 11, Data Integrity, and ISPE GAMP 5 lifecycle concepts (execution support level).
Experience supporting digital batch records, e‑logs, basic dashboards, and frontline analytics; comfort with SQL‑free or low‑code configuration environments.
Familiarity with resource management, production scheduling concepts, and OEE metrics (availability, performance, quality) and loss analysis.
Proficiency with MS Office; experience with QMS/LIMS/ERP at user or super‑user level is beneficial.
Alignment with Ardena’s CARE values: Communicative, Accountable, Reliable, and Excellent
Ability to bend, kneel, reach, and maneuver around equipment, HMIs, panels, and instrumentation.
Lift/push/pull up to 40 lbs for tools, laptops, interface devices, or small components; fine motor dexterity for terminals and small parts.
Work Environment/Safety Conditions:
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.
