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Injectables Technical Supervisor - Belgium  

Company managed [?] Still accepting applications

Posted on : 09 December 2016

Project Description

Scope:  
  • Supervise on a daily basis he Manufacturing Sterile Forms Technical and Maintenance activities. Scope :  Sterile Compounding & Filling, Automatic visual inspection 
  • Technical representative for Sterile Manufacturing projects (New & Continuous improvement) 
  • Lead Continuous Improvement initiatives on a Technical standpoint 
  • Key Manufacturing representative and point of contact for preventive maintenance strategy development 
  • Set in place a fact and data approach based upon KPI’s for dealing with technical manufacturing topics 
  • Build and control the maintenance operating budget in accordance with main stakeholder
     
Main responsibilities:
Technical Supervision    
  • Evaluate technical corrective actions during production when needed (stoppages, incident,…) 
  • Organize transversal contact with other services (Utilities, facilities, central maintenance, QA…) 
  • Accountable for the documental aspects of technical activities (OT, notification, SAP, technical docs, …) for sterile manufacturing activities 
  • Lead Daily, weekly and monthly technical meetings 
  • Supervises Maintenance technician(s) 
  • Follow-up on technical investigations in Trackwise Quality System 
  • Accountable of the design and execution of Level -1 Maintenance activities 
  • Accountable for safety rules respect in the area 
  • Technicians Back-up       
Productivity and Continuous Improvement   
  • Set preventative maintenance plan in collaboration with central maintenance team 
  • Execute with the team the first level interventions on the shopfloor 
  • Set in place a fact and data approach based upon KPI’s for dealing with technical manufacturing topics 
  • Identify and set priorities on technical improvement actions to be set in place 
  • Build and control the maintenance operating budget in accordance with main stakeholders 
  • Technical representative of the Sterile manufacturing area       
Quality & Compliance    
  • Accountablity for GMP compliance in all technical activities; 
  • Maintain the team in “Permanent Inspection Readiness” mode; 
  • Ensure all personnel has a training plan and is fully trained; 
  • Ensure compliance of all business-related activities (Customer Service Level, Adherence to Scheduling); 
  • Review and/or approve cGMP documents relative to Sterile Forms operations in compliance with our procedures and cGMP guidelines.       
Project Management   
  • Lead  technical projects (Capex and non-Capex) in Sterile Forms department, needed to execute BTO’s strategy and roadmap, in full respect of scope, budget and timelines  
  
Your profile:   
  • Bachelor’s degree required 
  • Master’s degree preferred 
  • 3-4 years minimum in manufacturing, experience in the pharma industry is a plus 
  • Experience in small team management 
  • Experience in project management 
  • Experience in continuous improvement Tools (TPM, 6-Sigma, etc…) 
  • Knowledge of GMAO systems 
  • Ability to work in a regulated environment (GMP, GDP) 
  • Knowledge in Mechanics, electricity, automation and pneumatic 
  • Knowledge of visual inspection technology is a plus 
  • Knowledgeable in Problem solving and continuous improvement tools (5S, 6-sigma, Lean, Kaizen,..) 
  • 6-sigma certification is an asset (Yellow Belt or Green Belt)  
    
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