Senior Process Engineer
Page Personnel Italia
Parma, IT
1 gg fa
source : Monster

pharmaceuticalcompany Dettagli sul cliente pharmaceuticalcompany Descrizione Responsibilities : · Provide specialized assistance to new investment projects development, in the industrial area, also directly following the assigned projects and their execution.

  • Draw up and / or check the necessary technical documentation and its completeness (user requirements, specifications, tests, user manuals, etc.
  • Carry out feasibility and improvement studies, if necessary, assisted by specialized engineering companies or other external consultants in the expertise area.

  • Set plants layout making sure that it conforms to the process characteristics and meets the criteria of : quality, safety, industrial hygiene and environmental protection.
  • Coordinate the activities of the Bulk and Pharma process plant manufacturers, when they are called to carry out the work.
  • Participate in the design, installation and machine and plant control systems testing on projects managed by other Project Managers.
  • He / she is responsible for its own area of expertise for all activities related to GMP, in particular packaging plants testing and qualification.
  • Follow Good Engineering Practice and, when necessary, apply both Good Manufacturing Practice and GAMP guidelines. · When necessary, provide adequate support for maintenance issues resolution.
  • Manage indipendently the assigned investment projects. · Keeping up to date with the plant engineering and technology evolution of the market and competitors.
  • Contribute to processes and Corporate guidelines implementation and distribution at corporate sites. Profilo del Candidato - Master Degree in chemical (preferred) or electronic engineering.
  • Required experience of at least 3 years in the pharmaceutical plants design or management. Preference is given to experience in sterile and biotechnological processes.
  • Technical skills : - Knowledge of pharmaceutical processes, in particular, sterile production. · Knowledge of process plants and industrial machines, instrumentation and control devices typical of the pharmaceutical industry.

  • Extensive knowledge of pharmaceutical regulatory references (FDA, EMEA, ICH, CFDA, etc.) concerning the environment, plant engineering, production and drugs control.
  • Knowledge of the main international pharmacopoeia and GMP (Europe, USA, PIC, WHO) and GAMP guidelines. · Knowledge of quality systems and standards of ISO : 9000 : 2015, ISO 14000, OHSAS 18000 series.
  • Knowledge of technical standards. · Preparation of test documentation and operating manuals. · Drug traceability and factory information systems.
  • Project Management. · Knowledge of legislation and general competence in the field of construction and procurement, including authorisation aspects with local authorities.
  • Personal skills : - Leadership and interpersonal skills. · Result orientation and planning skills. · Customer-driven and teamwork skills.

  • Preparation for work in a dynamic and multicultural environment. · Attitude for change. · Good stress management skills.
  • offerta di lavoro Permanent Contract.

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