Liam Callanan Email & Phone Number

Msd

• Technical lead on production shifts – supporting NPI/commercialisation• Supporting and introduction of Lean Processing in a RFT environment• Commissioning & Qualification of Production Equipment• Preparation of Technical Assessments, Risk Assessments, Strategy Documents, • Cleaning Validation including CIP/SIP• Site HTM 2010 Sterilisation SME• Site SME review of SAT2 & IOQ Documentation packs• Commissioning & Qualification of WFI, Sterile Air, Clean Steam… Show more • Technical lead on production shifts – supporting NPI/commercialisation• Supporting and introduction of Lean Processing in a RFT environment• Commissioning & Qualification of Production Equipment• Preparation of Technical Assessments, Risk Assessments, Strategy Documents, • Cleaning Validation including CIP/SIP• Site HTM 2010 Sterilisation SME• Site SME review of SAT2 & IOQ Documentation packs• Commissioning & Qualification of WFI, Sterile Air, Clean Steam, HVAC• Facility Qualification, (HVAC, Environmental)• Qualification of production equipment, e.g. TFF Skids, autoclaves• Lab Testing• Lead Problem Solving Teams – relating to Process Investigation Reports- CAPA’s NOE’s & DN’S• Regularly involved in Regulatory Authority Inspections as the Technical Lead.• Shipping Validation• PPQ Report and Protocol preparation review & execution• Formal Site Stability Protocol and Report preparation• Master Validation Protocol / Report preparation & review• PAI – preparation and State of Audit readiness Show less

Msd

• Project Lead for commissioning & Qualification of Building Facilities• Project Lead for HVAC system qualification for Building retrofit• Lead and Developed Building Environmental monitoring programme • Liaised with contractors and project management to meet aggressive schedule• Lead Process Performance Qualification of 15 vaccine serotypes• Technical Services Lead of process implementation• Technical Lead for process / equipment problem resolution• Worked shift… Show more • Project Lead for commissioning & Qualification of Building Facilities• Project Lead for HVAC system qualification for Building retrofit• Lead and Developed Building Environmental monitoring programme • Liaised with contractors and project management to meet aggressive schedule• Lead Process Performance Qualification of 15 vaccine serotypes• Technical Services Lead of process implementation• Technical Lead for process / equipment problem resolution• Worked shift pattern in a team environment to ensure smooth transition of process. Show less

Schering Plough - Msd

• Process Validation of upstream biological facility • Process Improvement – downstream recovery / protein purification process• Developed Strategies – continuous process improvement in a lean environment• Qualification & requalification of facility , utilities and equipment• Developed & introduced Schedule adherence system• On-going streamlining of processes• Cleaning validations and periodic monitoring• Developed and qualified porous and liquid load… Show more • Process Validation of upstream biological facility • Process Improvement – downstream recovery / protein purification process• Developed Strategies – continuous process improvement in a lean environment• Qualification & requalification of facility , utilities and equipment• Developed & introduced Schedule adherence system• On-going streamlining of processes• Cleaning validations and periodic monitoring• Developed and qualified porous and liquid load sterilisation cycles to meet HTM2010 standards Show less

Msc Biopharmaceutical Science, Biopharmaceutical, First Class Honours

Bachelor Of Business Studies, Economics & Finance, Honours Degree