Downstream Vaccine Process Engineer/Scientist - Dublin, Ireland - Cpl
Description
Cpl in partnership with our client Pfizer Grange Castle are currently recruiting for a
Vaccines Conjugation Process Scientists/Engineers
This role will be to provide process science and/or engineering support to the ongoing requirements of the Vaccines Drug Substance Operating Unit. The process scientist is responsible for providing technical support to the operating unit ensuring that processes are transferred to site as required and that they are robust, appropriately validated and run so as to maintain that validated state. The role requires flexibility to work within the project's technical transfer space and/or commercial technical services team.
We are seeking Process Scientists/Engineers whose role will be:
o Key member of the site technical services team, supporting the transfers and commercial manufacture of conjugated vaccines and representing the site at key internal and external meetings.
o Provide technical oversite of transfer activities
o Support Technology Transfer activities including Gap Analysis, Process Transfer Risk Assessment, Process Description etc.
o Routine process monitoring and address any significant issues/trends affecting the process robustness
o Support introduction of raw materials or consumables and assessment of Supplier Change Notifications (SCN)
o Ensure the process automation meets the requirements of the process
o Input to equipment specification process, including equipment sizing, specification of key components, verification documentation and process instrumentation ranges
o Liaise with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support routine processing and/or transfer activities
o Develop process trial/validation protocols and lead their execution in conjunction with Operations
o Generate process trial/validation summary reports and associated filing submissions.
o Lead major process investigations as requested, including preparation of process impact assessments and support the implementation of CAPAs
o Provide technical training on process and technology areas as required by the project.
o Provide independent decision making for strategic input into the facility & equipment design, support site operational readiness (equipment, process understanding etc.)
o Deliver presentations that distil complex ideas and proactively communicate results and progress to technical teams, management, and business leadership
o Be competent with Quality Systems, including Change Controls, Commitments and Maintenance systems
o Support Compliance Inspections and enquiries from Regulatory Agencies
About you:
o Minimum of 1 – 5 years' experience working in a manufacturing process; process development or tech transfer environment
o Knowledge of technical transfer
o Experience and knowledge of biological manufacturing processes
o Demonstrated aptitude for technical learning and problem solving
o Good communication skills (verbal, written)
o Experience of FDA and EU licensing desirable