Manufacturing Engineer

Overview

Ardena is a Contract Development and Manufacturing Organization (CDMO) partnering with pharmaceutical companies to navigate drug development with precision, quality, and speed. Ardena offers integrated services spanning drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support. With a growing international footprint, Ardena employs professionals across six locations in Belgium, the Netherlands, Sweden, Spain, and the US.

Our culture emphasizes collaboration, ownership, and innovation guided by our We CARE values. We foster an environment of mutual respect, accountability, and excellence. We are looking for skilled professionals eager to grow their careers in a fast-paced environment and contribute to meaningful drug development projects in a global team.

For the Ardena Business Unit based in Somerset (US), we are looking for a Manufacturing Engineer.

The Manufacturing Engineer supports Ardena’s GMP pharmaceutical and chemical processing operations by optimizing processes, designing and qualifying equipment, troubleshooting issues, and supporting technology improvements. This role ensures high-performance, audit-ready production environments across oral solid dose, chemical processing, and modernization initiatives.

• Process Engineering & Optimization
  • Analyze pharmaceutical and chemical processing workflows to reduce variability and improve throughput and yield.
  • Apply Lean, Six Sigma, and CI methodologies within GMP environments.
  • Maintain and optimize CPPs/CQAs, supporting CPV programs.
  • Revise batch records, SOPs, and controlled documents.
  • Improve operator ergonomics, safety, and line performance.
• System & Equipment Engineering
  • Specify, procure, and qualify equipment per sanitary design and contamination-control requirements.
  • Lead commissioning & qualification (IQ/OQ/PQ).
  • Support automation and data integrity compliance (ALCOA+).
• Troubleshooting & Investigations
  • Lead RCA investigations using 5
    
    Why, Fishbone, etc.
  • Own and execute CAPAs for sustainable improvements.
  • Provide on-floor engineering support to minimize downtime.
  • Partner with QA/Validation/Maintenance on deviations and equipment failures.
• Project Engineering & Technology Deployment
  • Manage equipment upgrades, modernization, and facility modifications.
  • Support tech transfer, scaleup, and NPI.
  • Lead risk assessments and engineering change controls.
  • Maintain project schedules, budgets, and documentation.
• Quality, Compliance & Documentation
  • Ensure adherence to FDA, EMA, ICH, ISO, and internal standards.
  • Support audits and implement corrective actions.
  • Drive process validation including characterization studies and PPQ.
  • Maintain strong documentation standards supporting data integrity.

• Bachelor’s degree in Chemical, Mechanical, Industrial, or Manufacturing Engineering preferred.
• 2–5+ years of experience in pharmaceutical, chemical, or other regulated GMP manufacturing environments.
• Experience with granulators, mixers, tablet presses, chemical reactors, extruders, or packaging lines.
• Lean/Six Sigma experience preferred.
• Hands-on experience with statistical software such as Minitab, JMP, or equivalent tools.
• Automation, SCADA, or MES experience a plus.

• Strong knowledge of cGMP, validation practices, and regulatory expectations (FDA/EMA/ICH).
• Proficiency in statistical analysis, including SPC, control charting, trend evaluation, and process capability (Cp/Cpk/Pp/Ppk).
• Experience performing Design of Experiments (DOE) and interpreting results to drive process understanding and optimization.
• Skilled in using statistical software (e.g., Minitab, JMP) for data modeling and CPV trending.
• Ability to interpret complex data sets from chemical and pharmaceutical processes using regression, correlation, and MVDA techniques.
• Experience applying statistical principles within risk assessments (FMEA, risk matrices, fault‑tree analysis).
• Strong documentation, technical writing, and data integrity discipline (ALCOA+).
• Proven capability in cross-functional collaboration and project execution.