14.04.2020
POSIZIONE CHIUSA
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
Responsibilities: - support the design development, procurement, factory acceptance testing, installation, commissioning and qualification of the Facility Utilities systems
- 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, Automation
- 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 (largader@lwphr.ch) who is in charge for the selection.
No reply will be given to the non-compliant applications.
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