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Palazzo PignanoPermanentFull-time

Process Engineer Finished Product & Sterilization

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Designs, implements and optimizes production processes, improving efficiency, reducing costs and ensuring compliance with current regulations for the production of medical devices.

Your assignments

·        Provides engineering support, including equipment/tools troubleshooting, training, upgrades, efficiency and safety improvements, etc.

·        Through the use of data, identifies and implements process parameters setup and changes that will improve quality and productivity

·        Supports new product launches and executes process changes related to: methods, parameters and material changes

·        Originates and investigates quality events using RCA

·        Writes and executes regulatory documentation including Operational Qualification (OQ) and Performance Qualification (PQ)

·        Leads the installation and validation of equipment

·        Builds internal/external system to support replication of best practices and lessons learned

·        Tracks equipment downtime, identify bottleneck, and report downtime appropriately

·        Implements and maintains std operations along all the production lines: layout plan, process improvement plan and execution, equipment capacity estimate

·        Supervises the implementation of Lean Management techniques in all the areas of the organization

·        Analyzes and identifies potential areas of processes improvement

·        Manages documentation and lean outcomes control, supervises improvement actions


·        Writes and reviews procedures concerning sterilization process and its validation tests   

·        Schedules validation and re-validation programs issuing the relative Validation Plan and Reports

·        Evaluates and approves validation protocols issued by external sterilization suppliers

·        Analyzes process or validation deviations and identifies corrective actions in agreement with QA

·        Checks the application of validated sterilization cycles in case of new product / change

·        Evaluates and analyzes any possible equipment change implemented by supplier by means of relative documentation checking

·        Receives/Performs the periodical inspection of sterilization norms and regulations and plans the purchasing of new revisions by issuing the gap analysis between versions

·        Provides training concerning sterilization process

·        Analyzes and identifies potential areas of improvement for sterilization process / documentation by attending the “best practices sharing plant to plant” meetings.

Your profile

  • Master degree or similar education level in engineering disciplines
  • At least 3 years of experience in similar positions

Technical knowledge, special trainings:

  • Good knowledge and understanding of PLC/SCADA/HMI systems
  • Knowledge of industrial control systems
  • Good Knowledge of smart camera vision system
  • Programming of PLCs, HMIs and SCADA – an advantage
  • Good knowledge of plastic parts assembly: welding (laser, ultrasonic), adhesive and mechanical fixing
  • Good understanding of the main process validation methodologies (process data analysis for the best parameters identification, set up and optimization)
  • Ability to apply fundamental engineering principles to process understanding, problem solving and process improvement
  • Strong Root Cause Analysis understanding
  • Lean Six Sigma Green Belt – an advantage
  • Expertise in FMEA’s
  • Knowledge of sterilizations process and relative norms

Important personal qualities:

  • Interpersonal savvy
  • Collaborates
  • Resourcefulness
  • Tech Savvy
  • Action oriented
  • Plans and aligns
  • Optimize work processes
  • Ensures accountability
  • Drives results
  • Instills trust
  • Nimble learning

Our offer to you

Permanent contract in a multinational context

Smart Working 

At a glance


InternationalPalazzo Pignano

Career level:

Professional Experienced

Job function:

General Engineering

Employment relationship:



Fresenius Medical Care

Reference number:


Publishing date:


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Your contact

Gaia Bertoni
Fresenius Medical Care Italia
Fresenius Medical Care Italia
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We welcome diversity

At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics.

All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse).

Careers with a purpose

When it’s not just a job, but your calling. When you have an impact on people’s lives every day. When you can’t imagine doing something else. Then you know it’s Fresenius.