Job Description

Principal Duties and Objectives

VLE Project Support

·       Working within a manufacturing team, co-ordinate the planning,
organising and delivery of the manufacturing  projects.

·       Prepare and review technical presentations and report material, and
present the issues, results and project progress to clients as required.

·       Based on project needs, develop and introduce new techniques, methods
and processes to improve business effectiveness.

·       Demonstrate the use of problem-solving skills requiring the application
of engineering principles, calculations and computational methods in
approaching technical challenges.

·       Adopt, maintain and improve on VLE’s engineering workflows and their
incorporation into the day-to-day execution of commercial projects and  where appropriate internal innovation
strands.

·       Generate ideas and suggestions on how to improve technical capabilities.

·       Coach mentor and train junior team members.

·       Represent the organisation at meetings, conference  or other events.

Technical Support

·       Provide support across the organisation through collaboration with
scientists and engineers, both internally and externally.

·       Ensure that operation to GMP standard within the facility is always
maintained.

·       Monitor, develop and optimise manufacturing processes.

·       Develop pharmaceutical scale-up and optimisation strategies through
application of engineering workflows and modelling tools which support the
successful tech transfer of the product to and from our partners.

·       Where applicable, support the execution of commercial and innovation
R&D projects using engineering modelling tools such as CFD, Matlab, Python,
MVDA, Dynochem etc.

·       Solve complex technical problems and take responsibility for
implementing the solutions.

• Ensure
  clear technical reports are written with sound conclusions. Author, review
  and approve reports a required. Ensure appropriate documentation write-up
  review/closeout is completed.
• Ensure
  that safe working practices are adhered to in line with relevant local and
  legal requirements.
• Liaise
  with the Engineering Manager as required to maintain a shared awareness of
  the issues requiring attention within the manufacturing facility.

Minimum Requirements

• Minimum
  of 5+ years in the BioPharma Industry 
• Experience
  in CQV, Commissioning, Qualification and Validation
• Experience
  in Project Engineering / Project Management Skills, equipment and SUT
  procurement  
• Experience
  in the operation of Autoclaves, Bioreactors, TFF, Chrome Skid advantageous
• Ability
  to work in a dynamic and multidisciplinary environment.

·       Self-motivated with demonstrated project management skills

·       Excellent technical communications skills, with previous technical
presentation experience

·       Ability to disseminate information to research team and directors

Desirable Skills

·       Demonstrated use of PAT

·       Previous
experience in Tech Transfer advantageous

·       Experience with scale-up techniques and /or tech transfer for processes
from laboratory to plant scale