What are the responsibilities and job description for the Engineering Specialist, Data & Master Data Transformation position at Ardena Careers?
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 [Job Title]
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, Data & Master Data Transformation
Department: Engineering
Location: Somerset (US)
Ardena is hiring an Engineering Specialist, Data & Master Data 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, Data & Master Data Transformation Specialist is a hands‑on execution role focused on master data quality, cross‑system alignment, and productivity across Ardena’s business platforms. The specialist creates, maintains, and harmonizes master data, executes data quality checks, supports UAT/CSV for data changes, and builds practical, operational reports/dashboards.
You’ll work across Operations, QC/AD, QA, Supply Chain, Finance, IT, and Engineering to ensure accurate, compliant, and trustworthy data that supports planning, inventory, manufacturing, labs, and regulatory activities—without owning enterprise data strategy or governance (owned by program/system leaders).
Key Responsibilities
Master Data Setup & Maintenance (Primary Focus)
Education and Experience:
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:
How To Apply
Ready to advance your career in pharmaceutical development? Apply now through the Ardena Careers website at careers.ardena.com.
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 [Job Title]
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, Data & Master Data Transformation
Department: Engineering
Location: Somerset (US)
Ardena is hiring an Engineering Specialist, Data & Master Data 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, Data & Master Data Transformation Specialist is a hands‑on execution role focused on master data quality, cross‑system alignment, and productivity across Ardena’s business platforms. The specialist creates, maintains, and harmonizes master data, executes data quality checks, supports UAT/CSV for data changes, and builds practical, operational reports/dashboards.
You’ll work across Operations, QC/AD, QA, Supply Chain, Finance, IT, and Engineering to ensure accurate, compliant, and trustworthy data that supports planning, inventory, manufacturing, labs, and regulatory activities—without owning enterprise data strategy or governance (owned by program/system leaders).
Key Responsibilities
Master Data Setup & Maintenance (Primary Focus)
- Create, update, and validate master data across systems such as ERP, QMS, LIMS (Sapio), MES/Mx, CMMS, and other digital platforms.
- Maintain metadata standards (controlled vocabularies/lookups/reference data) to prevent duplicates and conflicts across systems.
- Ensure change control documentation is captured for master data updates (forms, approvals, audit trail excerpts).
- Run scheduled data quality audits (completeness, uniqueness, validity) and execute remediation plans.
- Investigate tickets from lab analysts, planners, buyers, or QA reviewers; troubleshoot data issues to root cause and resolve or route appropriately.
- Maintain controlled spreadsheets/templates and data load files with versioning and approval records.
- Execute routine data cleanup, normalization, and remediation activities.
- Align Business Central master data with Sapio LIMS, MasterControl Mx / MES, QMS, and CMMS; support mappings, code tables, and reconciliation routines.
- Perform cross‑checks on transactions (e.g., receipts/consumption, inventory movements, batch/lot attributes) to resolve discrepancies and keep systems synchronized.
- Support UAT for data changes and interface updates; log defects, verify fixes, and escalate to IT or system owners as needed.
- Build fit‑for‑purpose dashboards/reports (e.g., item/lot readiness, open change objects, inventory data health, TAT/queue boards) using Power BI/Tableau/Excel.
- Provide standard extracts and data packs for cross‑functional reviews; highlight recurring issues and process waste.
- Follow ALCOA , 21 CFR Part 11, EU Annex 11, ISPE GAMP 5; support CSV/CSA deliverables for data‑impacted changes (URS inputs, risk assessments, test scripts, evidence, traceability).
- Assist with audit trail reviews (Business Central, LIMS, QMS, MES) and maintain documentation for data changes.
- Create job aids/checklists for master data requests, attribute standards, naming conventions, and lifecycle workflows.
- Provide 1:1 and small‑group training on data entry best practices and error‑proofing in Business Central and connected systems.
- Partner daily with Supply Chain, Finance, Operations, QC/AD, QA, IT, Engineering, and the Digital 4.0 Program Manager to prioritize data work and release calendars.
- Communicate clearly with requestors and system owners; escalate risks early and propose pragmatic fixes.
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.
- Proficient with Business Central item master, BOMs/routings/resources, inventory, lots/attributes, and basic production/order data; understands how ERP data supports planning, purchasing, manufacturing, and finance.
- Familiar with cross‑system mappings and code table harmonization (ERP/LIMS/QMS/MES/CMMS); able to assist with interface testing.
- Working knowledge of data integrity, Part 11, GAMP 5; can execute UAT/CSV tasks with documentation discipline.
- Reporting skills using Power BI/Tableau/Excel; basic SQL or low‑code tools a plus.
- High attention to detail and documentation rigor; strong communicator with cross‑functional teams.
- Problem‑solving mindset; able to manage multiple data workflows in a fast‑paced environment.
- 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.
- Frequent movement between office, lab, and production areas; ability to stand/walk and lift 10–40 lbs as needed; use of required PPE in controlled areas.
- Fast‑paced, priority‑driven environment requiring strict GMP and data‑integrity discipline.
- Routine interaction with Operations, QC/AD, QA, Supply Chain, IT, and Engineering; occasional off‑hours support for data releases or cutovers.
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
How To Apply
Ready to advance your career in pharmaceutical development? Apply now through the Ardena Careers website at careers.ardena.com.
Salary : $120,000 - $135,000