Engineering Specialist, Manufacturing Digital Transformation

• 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.

• 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.