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 USP1790 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***