The role:
PE Global is currently recruiting for a Technical Specialist on behalf of a leading pharmaceutical company based in Dundalk.
This is an initial 11 month contract role.
Responsibilities:
Provide Technical Leadership within the Drug Product manufacturing team including areas such as Formulation, Filling, Lyophilisation, Capping and Automated Visual Inspection.
Execution of equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ.
Coordinate technical deliverables within Drug Product to support the successful product launch.
Provide technical support to the operations team's during commercial manufacturing.
Lead/participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.
Support Batch Disposition activities by providing SME technical support for comment resolution.
Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Drug Product
Support continuous process and quality improvements through the deployment of Lean Six Sigma tools.
Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos.
In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DP organization.
Participate in Regulatory, Client and Internal audits inspections as the technical representative.
Education and Experience:
Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
Minimum 5 years working in biological, vaccine or pharma facility.
Preferred candidate will have cGMP with biological, vaccine or pharma facility with prior sterile manufacturing experience.
Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
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
Desirable:
Previous experience in an operations role within vaccine manufacturing preferred.
Knowledge of USP**** and industry/ regulatory requirements such as Annex 1 desirable
Ability to explain complex technical issues to external customers / agencies
Experience with lyophilized products advantageous
Experience in start-up facility advantageous
Demonstrated excellence in planning and organizational skills.
Demonstrated skills in communication (oral and written) & in particular technical writing.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on or alternatively send an up to date CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***