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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Drug Product Engineer Lyopholistation


Reference:SCA013227 Location: Louth
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Manufacturing Engineer

Senior Drug Product Engineer (Lyophilisation)
Our client, a global biopharma organisation, are currently recruiting for a Senior Drug Product (DP) Engineer (Lyophilisation) to join their team on a permanent basis. As Senior DP Engineer, you will ensure compliance with industry standards, oversee engineering policies and procedures, manage various aspects of equipment installation, validation, and maintenance to ensure the safe and effective operation of the start of the art manufacturing facility. You will provide technical and compliance review and/or authorship of testing protocols, reports and applicable manufacturing SOPs.


Responsibilities

  • Provide technical leadership within a new Vaccine Drug Product Manufacturing facility
  • Ensure all equipment installed is safe, effective and in compliance with industry standards
  • Ensure all company and site engineering policies and procedures are adhered to
  • Provide technical and compliance review and/or authorship of testing protocols, reports and applicable manufacturing SOPs
  • Lead Commissioning & Qualification activities for new equipment
  • Generate and execute documentation for cGMP activities including risk assessments and CQV protocols/reports
  • Management of Equipment Vendors including execution of SAT, on-site maintenance visits, management of continuous improvement projects & spare parts criticality assessments
  • Support/lead maintenance of the validated state of the equipment through execution of revalidation protocols
  • Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA
  • Manage changes to equipment/process as per site change control procedures
  • Support establishment of new Preventative Maintenance Program for equipment in Drug Product suite
  • Lead/participate in equipment related manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis & impact analysis is completed and appropriate CAPAs are implemented
  • Identify process and equipment improvements and develop these into CI projects
  • Support disposition of batches by addressing any potential technical / engineering related issues which may have occurred mid-batch
  • Lead/participate in, TPM, CI & Gemba programs and daily / weekly tiered manufacturing meetings
  • Participate in process, design & technical reviews with external clients
  • Provide technical expertise during regulatory inspections e.g. FDA, HPRA inspections to defend systems, change controls, investigations and qualification packages
  • Support transition from project to sustaining manufacturing and ramp up of production volumes in future by improving equipment reliability through CI and TPM processes
Requirements
  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline
  • Specific experience with Lyophiliser Freeze dryer equipment
  • Knowledge of Refrigeration processes
  • Experience in start-up facilities is advantageous
  • CQV experience is advantageous
  • Knowledge of industry/ regulatory requirements such as Annex 1 desirable
  • Ability to explain complex technical issues to external customers / agencies
  • Demonstrated excellence in planning and organizational skills
  • Demonstrated skills in communication (oral and written) & in particular technical writing
  • Minimum 5 years cGMP industrial / engineering experience
  • Experience in executing on the floor activities such as FAT, SAT, IQ/OQ
  • Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g. Six Sigma
  • Experience in leading & resolving complex technical investigations
  • Experience in a risk-based approach to manufacturing through use of tools such as FMEA
  • Ability to adapt to changing priorities as project demands change
  • Demonstrated excellence in planning and organizational skills
  • Demonstrated skills in communication (oral and written) & in particular technical writing
  • Ability to adapt to changing priorities as project demands change
For more information contact Sinéad Cullen on +353879500821 or si