Process Engineer
Chiesi Italia
Parma, Italia
3 gg fa

Accountability

Thecandidate, in the context of the department, will collaborate in the processes definition,design and selection, in the realization of plants and machines of the plannedinvestments, in support of the company's Strategic Plan.

CorporateEngineering projects and activities will be carried out both in Italy and inforeign countries, in Italian, English and sometimes local languages.

The mainproduction sites are Italy, France and Brazil, but the Corporate Engineering Serviceswill be provided in all the research sites and in all the commercial branchesaround the world.

Brief Description of the activities :

  • Provide specialized assistanceto new investment projects development, in the industrial area, also directlyfollowing the assigned projects and their execution.
  • Draw up and / or check thenecessary technical documentation and its completeness (user requirements,specifications, tests, user manuals, etc.).
  • Carry out feasibility andimprovement studies, if necessary, assisted by specialized engineeringcompanies or other external consultants in the expertise area.
  • Set plants layout making surethat it conforms to the process characteristics and meets the criteria of : quality, safety, industrial hygiene and environmental protection.
  • Coordinate the activities of theBulk and Pharma process plant manufacturers, when they are called to carry outthe work.
  • Participate in the design,installation and machine and plant control systems testing on projects managedby other Project Managers.
  • He / she is responsible for its ownarea of expertise for all activities related to GMP, in particular packagingplants testing and qualification.
  • Follow Good Engineering Practiceand, when necessary, apply both Good Manufacturing Practice and GAMPguidelines.
  • When necessary, provide adequatesupport for maintenance issues resolution.
  • Manage indipendently theassigned investment projects.
  • Keeping up to date with theplant engineering and technology evolution of the market and competitors.
  • Contribute to processes andCorporate guidelines implementation and distribution at corporate sites.
  • Study degree : Master Degree in chemical (preferred) or electronic engineering.

    Required experience : Required experience of at least 3 years in the pharmaceutical plants designor management. Preference is given to experience in sterile andbiotechnological processes.

    Technical skills :

  • Knowledge of pharmaceuticalprocesses, in particular, sterile production.
  • Knowledge of process plants andindustrial machines, instrumentation and control devices typical of thepharmaceutical industry.
  • Extensive knowledge ofpharmaceutical regulatory references (FDA, EMEA, ICH, CFDA, etc.) concerningthe environment, plant engineering, production and drugs control.
  • Knowledge of the maininternational pharmacopoeia and GMP (Europe, USA, PIC, WHO) and GAMP guidelines.
  • Knowledge of quality systems andstandards of ISO : 9000 : 2015, ISO 14000, OHSAS 18000 series.
  • Knowledge of technical standards.
  • Preparation of test documentationand operating manuals.
  • Drug traceability and factoryinformation systems.
  • Project Management.
  • Knowledge of legislation andgeneral competence in the field of construction and procurement, includingauthorisation aspects with local authorities.
  • Personal skills :

  • Leadership and interpersonalskills.
  • Result orientation and planning skills.
  • Customer-driven and teamworkskills.
  • Preparation for work in adynamic and multicultural environment.
  • Attitude for change.
  • Good stress management skills.
  • Languages : Fluency of English.

    Contract : Permanent Contract.

    Workplace : work base at Parma, but availability to act at other locations, also abroad,according to the assigned projects.

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