Candidatura

Our customer is an important company, operating in the pharmaceutical field in Ticino area.
We are beginning the recruitment process for the following profile:

MAINTENANCE MANAGER

  • support the design development, procurement, factory acceptance testing, installation, commissioning and qualification of the Facility Utilities system maintaining the utilities and process equipment once the site is fully GMP.

  • responsible during the project for the commissioning and qualification of the Industrial Services and Clean Services

  • maintain and operate the utilities and process equipment

  • ensure that commissioning and qualification activities are performed according to GEP, GMP, GAMP respecting current technical, environmental and safety norms

  • contribute to project success by managing milestones and respecting defined budget

  • define and ensure that User Requirements are followed in collaboration with key users and participate to procurement process and suppliers selection

  • as maintenance expert, participate to the design development of the biotech process equipment

  • ensure that appropriate project documentation & training is provided at project’s hand over and prepare the spare part inventory at project’s reception

  • develop and implement the overall preventive, corrective and predictive maintenance programs

  • develop maintenance procedures and work instructions for the Facility systems

  • develop the maintenance training program and provide training to operative staff

  • develop, implement and then administrate the Site’s maintenance planning system for tracking maintenance work orders, spare parts and maintenance history of plant equipment

  • ensure that the systems are operated and maintained by strictly following the technical norms, safety rules and GMP regulations

  • keep records of equipment failures and provide needed information and data to the equipment owners

  • manage all technical related issues that will affect the day to day operation of the new plant

  • ensure a complete traceability of the maintenance and qualification activities following the Company's compliance procedures and cGMP rules

  • contribute to the development of Site’s standards

  • ensure that the systems are ready for inspection at all time and provide support during regulatory inspections

  • ensure close collaboration with operation users and QA and contribute to continuous improvement of the systems and processes overall

  • ensure that all procedures and technical documents are updated according to the Site quality documentation systems

  • in collaboration with QA and Manufacturing department, contribute to the harmonization of the commissioning and qualification activities that are  planned within the project

  • stay up to date on latest industry standards

  • ensure safe working conditions

  • contribute positively to a strong culture of business integrity and ethics

  • act within compliance and legal requirements as well as within company guidelines

    Requirements

  • technical and/or Engineering educational background preferably in Mechanics, Electricity, Automatio

  • 7+ years of experience in the pharma/biotech manufacturing environment

  • good knowledge of Biotech/Pharma Utilities systems and equipment

  • understanding of electrical standards and local requirements, certifications

  • strong project management skills with good knowledge of Design, Construction activities

  • strong interpersonal and communications skills, written and oral

  • fluent in English and Italian. Knowledge of German is a plus

  • broad and experiential knowledge of Pharmaceutical Quality, Manufacturing and GMP practices

 

If your experience fits with the listed requirements please send your application to Mr. Alberto Largader ([email protected]) who is in charge for the selection.

No reply will be given to the non-compliant applications.

Ledermann
Via Vegezzi 4
6900 Lugano

Ledermann Wieting & Partners SA
+41 (0) 91 921.48.78
+41 (0) 91 921.45.69