Carl Egan Email & Phone Number

Dublin, County Dublin, Ireland

County Dublin, Ireland

Dun Laoghaire

• To follow and comply with all SOP's, cGMP's and EHS requirements.• Responsible for performing Area Clearances.• Set up and operation of Y-cone blenders and Matcon IBC blenders.• Blending of pre-blends and master blends.• Real time documentation of batch activities into BMR’s and PI sheets in a SAP application.• Recording weights of good product, samples and rejects in BMR and SAP.• Ensure that all drums of product are identified and labelled correctly.• Notify Production Supervisor of any anomalies or issues that may affect product quality.• Disassembly and cleaning of blenders and associated parts.• Cleaning of Process Areas and rooms.

• To follow and comply with all SOP's (Standard Operating Procedures), cGMP's (Good Manufacturing Practice) and EHS (Environment, Health & Safety) requirements.• To perform Area Clearances and check in batch materials.• Set up and operation of tablet press including installation of punches and dies.• Compression of tablet blend into cores / tablets.• Real time documentation of batch activities into Batch Manufacturing Records (BMR’s) and Process Instruction (PI) sheets in a SAP application.• Performing routine In Process Checks (IPC’s) to ensure tablets meet acceptable criteria.• Monitor the automated In Process weighing of tablets to ensure that checks are being performed at expected intervals.• Recording weights of good product, samples and rejects in BMR and SAP.• Ensure that all drums of product are identified and labelled correctly.• Notify Production Supervisor of any anomalies or issues that may affect product quality.• Disassembly of tablet press and cleaning of press and associated parts.• Cleaning of Process Areas and rooms.

Sterile Ipt

* Responsible for performing Area Clearances and Verification of Area Clearances.* Cleaning, assembly & sterilisation / sanitisation of equipment for Bulk Manufacturing and Filling.* Responsible for the set-up and operation of CIP cycles (Clean In Place) and SIP cycles (Sanitize in Place) on the Bulk manufacturing skid.* Responsible for the Bulk Manufacturing & Filtration of Sterile products (infertility, steroid, anaesthesia and reversal agent) and associated Quality checks. * To aseptically fill and Terminally Sterilise products.* Visual Inspection of filled vials during the filling process.* Operation of Production Autoclaves and Terminal Steriliser.* Set-up and operation of VHP cycles (Vapourised Hydrogen Peroxide) on the vial filling enclosure (RABS).* Set-up and operation of the Vial Filling line, Ampoule filling line and Freeze Dryers.* Operation of the Bulk Manufacturing skid.* To make machine/equipment adjustments where necessary.* Responsible for the Quality Control Integrity testing of Product filters and gassing filters pre and post use.* To perform Particle Counting as part of batch specific environmental monitoring and quarterly particle counts for room qualification. * To operate in Grade A, B, C and D cleanrooms, following cGMP (Good Manufacturing Practice) and good cleanroom behaviours.* To update master copies of Batch Records (Batch Files).* To update Standard Operating Procedures (SOP's) and controlled worksheets in MIDAS.* To train new and existing Process Technicians.* To follow and comply with all SOP's, cGMP's and EHS (Environment, Health & Safety) requirements.* To participate in and support all improvement initiatives (Lean Six Sigma, Merck Production Systems, Right First Time)* Yellow Belt Certificate in Lean Six Sigma.

Sterile Ipt, Specialty Packaging Ipt

* Lead and manage the Production team.* Deliver output to planning schedule.* Ensure compliance with Quality, cGMP and EHS requirements.* Identify, lead and implement continuous improvement opportunities.* Own Permanent Inspection Readiness for area.* Consistent delivery of KPI's (Key Performance Indicators).* Ensure production team is trained in all relevant tasks.* Review Batch documentation.* Update SOP's, Batch Files and controlled worksheets as required.* Lead Tier 1 meetings.* Attend and participate in Tier 2 meetings.* Raise GMP and EHS Topics as required.* Raise Deviations when required.* Execute and implement CAPA's (Corrective Actions, Preventive Actions).* Lead investigations using the 5 WHY'S.

Certificate In Science, Biopharmaceutical Processing

Level 6

Leaving Certificate