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Process Engineer / Fertigungstechniker/in

Req ID: J2261413

  • Location
    Bettlach, Solothurn, Switzerland
    Grenchen, Solothurn, Switzerland
  • Category Engineering
  • Posted Tuesday, February 16, 2021
  • Type Full time

Job Description


Planen und Durchführen von Qualifizierungen/Validierungen von neuen und bestehenden Produktionseinrichtungen und -prozessen von Synthes Europa,

unter Berücksichtigung der wirtschaftlichen, qualitativen und kundenorientierten Aspekte.

Beschrieb von Aufgaben- und Verantwortungsgebiet

  • Planung und Durchführung der notwendigen Aktivitäten für die Qualifizierung / Validierung von Maschinen und Prozessen in der Produktion 
  • Erstellung der zur Qualifizierung / Validierung erforderlichen Dokumente in Zusammenarbeit mit der Produktion, Instandhaltung, Quality Engineerings 
  • Mitwirkung bei der Planung und Umsetzung von Korrekturmassnahmen von Qualifizierungen / Validierungen
  • Lenkung und Pflege der für die Qualifizierung / Validierung relevanten Dokumente im vorhandenen PDM-System
  • Festlegen von Prozessparameter und Durchführen der Prozessvalidierung von IQ, OQ, PQ, TMV und CSV
  • Erstellen und ändern von Fertigungsdokumenten
  • Sicherstellen der Produktion unter den Gesichtspunkten der Funktion, Qualität und Wirtschaftlichkeit
  • Unterstützung des Business bei der Durchführung von Validierungen
  • Erstellung von Plänen und Berichten für die Validierungsdokumentation
  • Planung und Durchführung von Schulungen
  • Kennen und Befolgen der Richtlinien bezüglich Verhaltenskodex, Ethik- und Compliance Programmen sowie anderer relevanter Regelungen

Abgeschl. Berufsausbildung plus mind. 5 Jahre prakt. Erfahrung und zusätzliche berufliche Weiterbildung wie Meister, Techniker, Fachhochschule

Erfahrungen in der Prozess-, Computer System- und Testmethodenvalidierung 

Persönliche Eigenschaften

  • Lernfähigkeit
  • Organisationsfähigkeit
  • Effizienz
  • Flexibilität  
  • Eigeninitiative
  • Teamfähigkeit
  • Belastbarkeit

Sprachliche Mindestanforderungen

Deutsch: Sehr gut  

Englisch: gut

Add value through knowledge about process engineering; supports stabilization and the continuous improvement projects life cycle since its identification to the execution and closure in terms of cost, quality, efficiency and time cycle Rapid response to operations in: technical resolution, direction change, manufacturing scalability,
process/product development and replacing materials. Completes projects within the site or with suppliers, to provide an uninterrupted flow of component for assembly operations that meet instrument, quality, cost, and delivery requirements

• Under general supervision, conducts assignments involving a specific portion of a project. May assist in determining objectives and planning schedules of multiple projects with few complex features.
• Must know and follow rules, policies and procedures of the company that are related with work activities within responsibility area, must assure that the subordinates know and follow sam rules, policies and procedures.
• Complete training in responsibility area, within the time assigned. Training is required fo changes and implementation of policies, existing procedures, new functions, etc. Complete retraining required in areas such as Safety and Environment.
• Follow all safety policies of the company and all the safety measures within work area.
• Promote Safety work environment to all workplace associates.
• Responsible for leading and executing projects focused in the variation reduction originated by process and/or design of the product that positively influences in the business metrics, strategic direction and financial results.
• Keep work plans through the year, such as change in base product design (product line extension), process changes and cost improvement projects.
• Identify and execute supply chain manufacturing and/or suppliers cost improvement projects.
• Lead technical projects within manufacturing site or suppliers to improve process capacity capability, yield and maintainability.
• Provide technical support for the approval/ validation of changes/ improvements within manufacturing site or supplier processes
• Provide technical support for the resolution of component quality issues
• Potentially perform supervision functions in ME technical areas (PROJECTS/CAD/BOM).
• Sustain supply chain continuity by qualifying and validating site and/or supplier tooling as per component approval procedures.
• Ensures closure to component non-conformance issues with timely corrective action submission and approval of site and/or suppliers control plans.
• Other responsibilities may be assigned and not all responsibilities listed may be assigned

• Job is NOT directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).

• Group integration, multifunctional tasking and coordinates collaboration between multiple functional groups.
• Bilingual German / English
• Effective communication, oral, written and for presentations.
• Project management, lead teams located in different areas while executing a Project.
• Technical competencies, preferred
• Tool design
• Product/Process risk evaluation
• Cleaning Validation
• Design and automation of equipment
• Interplant transfers
• Design and validation of proof methods
• Lean and Six Sigma skills
• Process validation
• Design validation and verification Assembly and equipment process development
• Metrology and calibrators development
• PLC (troubleshooting)
• Credo acting values and behavior
• Company Process and product knowledge
• Quality system knowledge
• GMP/ ISO knowledge
• Computer skills
• Proficient in Word processing, spreadsheets, presentations and databas applications.
• Statistical analysis software
• Engineering software (FEA, CAD, etc) as it applies.
• Other skills may be required and not all skills listed may be utilized
• Bachelor of Science in Engineering
• Technical formation preferred
• Advanced Degree in Science or Engineering preferred
• Masters or PHD preferred
• 0 - 2 years of experience in a product development and/o manufacturing environment
• Experience in medical product industry is preferred.

Accessibility Accommodation

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to or by calling 1.727.803.7515 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address and/or phone number.

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