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Qualification-/Validation-Ingenieur

Location: St. Gallen, Switzerland Salary: competitive
Sector: Engineering Type: Contract

Qualification- / Validation-Ingenieur

Job Requirements

Formal Education and Training

Degree in Engineering, Production Technology, MBA

Occupational Experience

5 Years of experience engineering and qualification of pharmaceutical equipment in a global environment and in intercultural

Project teams, thereof at least 3 years with the responsibility for qualification for pharmaceutical equipment. Experience in multi

Project management.

Additional Knowledge Requirements

Strong qualification capability regarding the cGMP and GAMP guidelines, structured and methodical working style (e.g. FMEA,

SWOT, TCO), team-oriented, communicative, highly self-motivated and proactive, result-driven, business fluent command of

English, multi-tasking capabilities, intercultural leadership skills and lean knowledge desired.

Major Duties

  • Documentation / Qualification
  • Supports the execution of the equipment qualifications for all global technology projects and process improvements
  • Ensures that all guidelines (e.g. IMSU, EHS) and as well as all national laws are applied in the projects in case of qualification
  • Supports the production sites worldwide in case of qualification for equipment's and/or processes if requested
  • Supports the execution of the process validation if required from internal customers

  1. Continous Improvement
  • Supports the continuous improvement of the qualification process and documents for pharmaceutical equipment regarding the GMP/cGMP guidelines
  • Supports a professional platform with interaction of Pharmaceutical Systems internal departments as well as other departments (BU, SBF, CS, CF) and third party professionals

  1. Projects
  • Leads Qualification sub-projects and/or Qualification-work packages for technology projects

  1. IMSU / EHS / cGMP / Guidelines for pharmaceutical supplier industry
  • Ensures adherence to and monitoring of legal laws and internal regulations concerning IMSU/EHS/cGMP/ guidelines for pharmaceutical supplier industry/Safety regulations in his/her organization and occasionally involved in the development of new concepts and directives in close cooperation with the IMSU/EHS team and external certified bodies.
  • Ensures implementation of the concepts in his/her area of responsibility and takes care of the corresponding instruction and training of his/her employees.

  1. Corporate Code of Conduct, Labor Safety, Environment Protection and Quality Management
  • Deals in compliance with the Corporate Code of Conduct
  • Ensures that IMSU and Risk Management guidelines as well as national laws are applied in his area of Responsibility

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.