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Looking for a challenge and a chance to grow your career?

Then Incyte is the pharmaceutical company for you. While our pipeline demonstrates the ability to compete with much larger pharmaceutical companies in selecting compelling targets and creating high-quality drug candidates, our smaller size enables employees to see the direct impact of their contributions on the direction of the company. Due to our smart, agile culture and cutting-edge science, we delivered a novel, first-to-market product in an unmet medical need in 2011 - the first in the company's history.

Opportunities for taking on new and/or additional responsibilities, in addition to advancement, are a key element in our culture. Add to that a science-based, fast-paced work environment and you’ve got an exciting company in which to work.

In addition to opportunities for growth, we offer an outstanding benefits andcompensation package to help meet personal needs as well.

Take a look at our current openings to find the match that’s right for you!

Incyte Corporation values the talents of our diverse workforce and is proud to be an Equal Opportunity Employer.


Maintenance Manager

Department: Biologics Commercial Manufacturing
Location: Incyte Biosciences Technical Operations Sŗrl - Yverdon

 

Summary

 

 

 

The Maintenance Manager for the new Incyte Biologics Facility at Yverdon-les-Bains is responsible to support the design development, procurement, factory acceptance testing, installation, commissioning and qualification of the Facility Utilities systems utilized in the production of biopharmaceutical drug substance during the construction phase and maintaining the utilities and process equipment once the site is fully GMP.

 

 

 

Duties and Responsibilities

 

Responsible during the project for the commissioning and qualification of the Industrial Services (Plant steam, heating and cooling systems) and Clean Services (Purified Water, WFI, Clean steam, Process gaz, HVAC) and then in charge to maintain and operate the utilities and process equipment to support biopharmaceutical drug substance manufacturing quantities with the required quality level.

 

During the construction phase, you will mainly:

 

  • Ensure that commissioning and qualification activities are performed according to GEP, GMP, GAMP respecting current technical, environmental and safety norms as well as following internal standards and Company guidelines 

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

  • Define User Requirements 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 projectís hand over and prepare the spare part inventory at projectís 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 where appropriate

  • Develop, implement and then administrate the Siteís CMMS and associated maintenance planning system for tracking maintenance work orders, spare parts and maintenance history of plant equipment

  • Develop the maintenance and troubleshooting organization

 

During operational phase, you will mainly:

 

  • Ensure that the systems are operated and maintained by strictly following the technical norms, safety rules and cGMP 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 Siteís 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

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

  • Good knowledge of Biotech/Pharma Utilities systems and Biotech equipment

  • Understanding of electrical standards and local requirements, OIBT certification art 13 or 15 is a plus

  • Strong project management skills with good knowledge of Design, Construction & C&Q activities

  • Strong interpersonal and communications skills; written and oral

  • Fluent in English and French

  • Travelling may be required

  • Broad knowledge of Pharmaceutical Quality, Manufacturing and GLP/GCP/GMP/GAMP practices

 

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