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Senior Operations Engineer

Job Title: Senior Operations Engineer
Contract Type: Permanent
Location: Brisbane
Industry:
Reference: 725140
Contact Name: Peter Starling
Job Published: May 17, 2021 12:01

Job Description

Vaxxas is a fast growing and scale-up stage biotech company developing a novel vaccine delivery system that safely and cost effectively amplifies vaccine efficacy. It is an advanced platform that vaccinates by applying a patch to the skin for a few seconds directly depositing vaccine amongst dense population of key immune cells.

Reporting to the Head of Clinical Operations & Supply, the Senior Operations Engineer is primarily responsible for supporting the handover and ongoing operation of process equipment developed by the Vaxxas Engineering department into Operations, ensuring that all activities are completed and documented in accordance with cGMPs and relevant regulations and international standards.

From an operational and delivery perspective, the Senior Operations Engineer will be:
  • The representation of the Operations team on projects under design and development in the Engineering team ensuring the equipment meets the user requirements of manufacturing and quality.
  • The handover and validation of equipment developed by the Engineering team ensuring the equipment meets the requirements of cGMP.
  • The ongoing operation of manufacturing equipment used at Vaxxas.
  • The procurement of “off the shelf” equipment associated with Operations including manufacturing and facilities.
The position will work to introduce process improvement methodologies, as well as training other team members in implementation of the production equipment.
 

 

To be successful in this role you will have experience in a Senior Operations Engineer role within a similar company. You will have experience across the following:

 

  • Applicants should possess a relevant undergraduate degree in Engineering.
  • Good knowledge of pharmaceutical GMP, manufacturing processes, materials, equipment and process design
  • Experience in the design of process equipment for complex manufacturing environments, use of CAD design tools (Solid Edge preferred)
  • Capable of generating detailed engineering component/assembly drawings and experience in co-ordinating fabrication of custom hardware via machine shop staff, engaging with external (incl. international) suppliers to complete equipment build within timelines.
  • Electronics/Mechanical/Analytical XFT, with a team oriented mindset.
  • Experience in executing complex problem solving techniques related to manufacturing/design technical issues.
  • Demonstrated ability to lead or facilitate projects using lean methodologies from inception through implementation of recommendations and solutions.
  • Ensure quality of process and equipment as defined in the appropriate operation and material specifications.
  • Will analyze equipment to establish operating data, assist in experimental test and result analysis.
  • Participate in PFMEA and SOP generation associated with equipment transfers and launches.
  • Authorship of Qualification documentation. Experience in implementation of GAMP preferred.
  • Experience with pharmaceutical GxPs desirable
  • A practical, hands on mindset is required.
  • Demonstrated problem-solving skills, task orientated with a solution focused approach.
  • Manage priorities and tight timeframes - Self-motivation in achieving goals and a positive mindset towards this.
To be considered, please submit your resume and a cover letter (outlining your core capability for the role, demonstrated experience of how you have delivered outcomes and why this role is of interest) both in Word format by selecting the “apply now” function. 

Confidential enquiries can be made to Peter Starling, Client Partner on 07 3305 5830 or 0433 422 518.

 

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