Senior Maintenance/Facility Compliance Manager

Location: 

Basel Area - Allschwil, CH

 

 

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bring R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 800 highly qualified specialists dedicated to realizing our ambitious targets.

 

We are looking for a Senior Maintenance/Facility Compliance Manager for our GMP Clinical Manufacturing Units with a strong background in Sterile facility operations.

 

Responsibilities :

 

  • Ensure Clinical Manufacturing Units operational readiness by supporting equipment and facility procurement, installation and (re)qualification, troubleshooting, technical maintenance and facility management according to cGMP standards and Idorsia procedures.
  • Monitor the work of outside contractors when installing, repairing or investigating equipment within the facility.
  • Define, coordinate, conduct cleaning and sterilization verification / validation activities as well as microbiological monitoring in collaboration with Quality Control / Quality Assurance.
  • Review, write, modify, and improve facility and equipment standard operating procedures (SOPs).
  • Manage and represent the team in facility or equipment related change controls, deviations, CAPAs
  • Support the internal, external and Health Authorities inspections.
  • Set up and manage Health and Safety, security systems with support of H&S department. Acts as facility safety officer.
  • Ensure the functional management of associates and trainees, taking responsibility for performance management and staff development. Create optimal working environment to ensure a dynamic, committed team and effective operations.

 

Requirements :

 

  • Master’s degree in a relevant field (Pharma/Chemical Engineer, Mechanical Engineer, Technical Engineer or equivalent)
  • 7 years of experience in a pharmaceutical technical field (maintenance, validation, production systems, facilities and equipment) under quality systems or GMP compliance
  • 3 years of experience in a development, clinical or commercial for Sterile manufacturing.
  • Knowledge or experience in qualification and/or maintenance of GMP fluids, filling line and/or autoclave
  • Experience in Environmental Monitoring and Computer system is an asset
  • Skilled to collaborate with professionals effectively
  • Well-developed planning and organization skills
  • Self-achiever
  • Excellent communication and team working skills
  • Ability to prioritize and work under time pressure
  • Fluent in English (German or French would be an advantage)

 

 

What Idorsia offers

 

  • Exciting opportunities for development and professional growth within our dynamic organization
  • A collaborative and solution-oriented environment where you can make a difference
  • An innovative and open culture in a truly multicultural environment
  • A competitive salary and generous benefits

 

Work  Location: Basel Area - Allschwil

Country: Switzerland

Business Area: Pharmaceutical Development - GMP Clinical Manufacturing Units

Schedule: Fulltime

Job Type: Permanent

Job ID: 1466

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.