Automation Engineer Manager

On Application
19 Nov 2018
19 Dec 2018
Quality, QA / QC
Contract Type

Job Summary (Primary function)

  • The Automation Engineering Manager for the new Biologics Facility is responsible to support the design development, procurement, factory acceptance testing, installation, commissioning and qualification of the new Automation systems utilized in the production of biopharmaceutical drug substance during the construction phase and the operational phase once the site is fully GMP.

Essential Functions of the Job (Key responsibilities) 

  • Responsible for the Facility and Process automation systems.
  • Develop and implement the Facility and Process automation architecture & systems based on the Site requirements and industry best practices
  • Administrate and maintain the Facility and Process automation systems to ensure system readiness and robustness at all time
  • Manage automation projects with respect of the Site change control procedure
  • Establish and maintain automation support model along with industry standards
  • Contribute to project success by managing milestones and respecting defined budget
  • Define User Requirements in collaboration with key users and participate in procurement process and suppliers selection
  • Actively participate in process and technology transfer as it relates to automationEnsure 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
  • Ensure that appropriate project documentation & training is provided at project’s hand over
  • Contribute to the development of Site’s standards for the automation systems
  • Manage all automation related issues that will affect the day to day operation of the new plant and investigate automation issues in a manufacturing environment
  • Develop the automation maintenance system and related troubleshooting organization
  • Manage automation systems lifecycle by implementing regular automation upgrades and improvements
  • Ensure close collaboration with operation users and contribute to continuous improvement of the Automation systems and processes overall
  • Ensure that the automation systems are ready for inspection at all time and provide support during regulatory inspections
  • Ensure that all procedures and technical documents are updated according to the Site quality documentation systems
  • Provide training to maintenance and operative staff where appropriate
  • In collaboration with QA and Manufacturing department , contribute to the harmonization of the commissioning and qualification activities that are planned within the project
  • Remain current 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

Qualifications (Minimal acceptable level of education, work experience, and competency)

  • Engineering educational background preferably in Automation, Bio and/or Chemical processing
  • Minimum of 7+ years of experience in the biotech engineering/manufacturing environment with automation systems
  • Experience with DCS and PLC coding. Good knowledge of Rockwell, DeltaV and Siemens platform is a plus
  • Experience with DCS/PLC/Automation system installation & validation and support/troubleshooting
  • Good knowledge of Biotech/Pharma Utilities systems and/or Biotech equipment
  • Understanding of electrical standards and local requirements
  • 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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