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ATS Company:  Comecer
Requisition ID:  3505
Location: 

Rolling Meadows, IL, US, 60008-3833

Date:  Feb 23, 2021

Installation and Commissioning Manager - North America

Job Description

OVERVIEW:
This individual is an important contact for Comecer customers during and after project implementation with the final user of the system. The Installation and Commissioning Manager – NA is a supervisory team member who will lead the development of Comecer’s installation and commissioning capability for Radiopharma, Pharma and Cell & Gene Therapy (ATMP) projects in North America; these include, but are not limited to:

  • Radiopharma – shielded hot cells and automation, synthesis and dispensing modules for vials and syringes, LAF shielded isolators, sterility testing isolators, VPHP generators for sterilization, solid target processing systems, dose calibrators, glove testers, and VPHP sterilization modules
  • Pharma  – aseptic handling and filling of liquid and powder APIs, dispensing custom R&D isolators, potent API processing Isolators (PAPI), modular sterility testing isolators (MSTI), ATEX isolators, Baby Phill small batch vial filling, Combo Phill aseptic filling line for RTU vials syringes, cartridges, fully automated combination product end-to-end filling systems, Speedy Glove, DeconBox™
  • Cell & Gene Therapy (ATMP) – modular cell culture isolator (MCCI), incubation system for advanced therapy labs FlexyCult™
  • Installation and Commissioning include SAT, IQ/OQ and Validation activities

 

ESSENTIAL JOB DUTIES:

Installation and Commissioning

  • Produce and implement the installation and commissioning plan for projects in NA
  • Ensure the process achieves performance and contractual requirements.
  • Ensure a safe working environment at site.
  • Supervise Comecer personnel for the successful installation, SAT, IQ/OQ and validation of Comecer equipment. 
  • Ensure that projects have required resources to perform the different activities required and all material, facilities and tools are on site.
  • Ensure all equipment is maintained correctly; approve any significant expenses associated with installation and commissioning activities. This work may occur across several different work sites in parallel.
  • Lead the creation of Standard Operating Procedures (SOP) for installation and commissioning of Comecer equipment.
  • Mitigate risks associated with projects schedules to ensure on time completion.
  • Coordinate activities of internal ATS personnel from other divisions as well as 3rd party contractors associated with installation and commissioning activities.

General

  • Recruit, train, inspire and manage installation and commissioning personnel
  • Participate in design review meetings 
  • Collaborate with Director of Comecer NA to define budgets and forecasts
  • Liaison with Comecer Project Managers and Operations personnel.
  • Any other duties commensurate with the position as may be assigned from time to time by the Director of Comecer NA
     

Additional Information

QUALIFICATIONS

  • Bachelor’s degree or post-secondary education in engineering, nuclear medicine, microbiology, or business
  • A formal qualification in a relevant engineering discipline
  • Significant demonstrable experience in an installation/commissioning role 
  • Excellent time management, leadership, and organizational skills  
  • Familiarity with RadioPharma, Pharma and Cell and Gene Therapy Disciplines preferred
  • Ability to interpret mechanical and electrical drawings
  • 5+ years experience troubleshooting electrical and mechanical faults on industrial equipment 
  • Basic understanding of factory automation systems and equipment including PLC’s robotics and software programming
  • Proficient using MS Office Suite (Outlook, Word, Excel, Project)
  • Ability to read, speak, write, & understand English in a professional manner
  • Must be eligible and able to travel domestically & internationally, up to 50%, within 30 days from hire date and legally eligible to operate a vehicle, as this is an essential job function
     

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