| 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 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).
Execute defined configuration tasks in MasterControl 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; escalate issues promptly.
Provide day‑to‑day user support: triage tickets, troubleshoot basic issues, and coordinate with IT/Automation for resolution.
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).
Enable data capture for OEE, downtime categorization, and basic production analytics; develop or maintain frontline dashboards in collaboration with Operations and IT.
Operations & Continuous Improvement
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.
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).
Ensure solutions meet 21 CFR Part 11, EU Annex 11, and data integrity expectations; maintain accurate configuration notes and change records.
Change Management & Training (Execution)
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.
Cross‑Functional Collaboration
Partner daily with Operations, Supervisors, QA, QC, IT, Validation, and Engineering; communicate clearly in a production environment and escalate risks early.
Coordinate planned go‑lives and minor releases to minimize production impact; occasional off‑hours support during implementations.
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).
Hands‑on exposure to MES (MasterControl Mx preferred), e‑batch records, or digital shop‑floor tools.
Knowledge/Skills:
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.
Collaboration skills with Automation/Engineering for SCADA/PLC/IIoT connectivity (no PLC programming required). Ignition (Inductive Automation) knowledge is a plus.
Strong troubleshooting, documentation, and communication skills; able to translate operator feedback into actionable configuration changes.
CI mindset (Lean/Six Sigma tools for problem‑solving, standard work, and error‑proofing).
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
Physical Requirements:
Frequent on‑floor presence in GMP areas; ability to stand/walk for extended periods and move between production suites, mechanical/utility spaces, and offices.
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.
Wear required PPE (gowning, safety glasses, gloves; respirator where applicable)
Work Environment/Safety Conditions:
Regular work around active production equipment and automated systems; strict adherence to site safety, GMP, and data‑integrity practices.
Required compliance with gowning and PPE procedures for controlled areas; exposure to typical production‑floor conditions (moderate noise, temperature variation, equipment movement).
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.