PSC is hiring a Biotechnician in Cork, Ireland.
Overview:
* Reporting to the Drug Product Team Lead, the successful candidate shall work as part of a team of Sterile Filling Technicians to complete both the manufacturing and visual inspection of sterile drug product as per the schedule for onward processing in the packaging facility.
* The candidate will be required to work closely within a cross-functional team including other Sterile Filling Technicians, Maintenance Technicians, Quality, Material Operations, Supply Chain and others.
* This is a 12 Month contract role with possibility of extension
Requirements
* This role requires flexibility with regards to work schedules. This role is currently a 3-Shift rotation (3 Shift Rota (12hr) + 25%) with potential for future shift work changes as required:
* Demonstrate technical knowledge and experience in cleanroom operations incorporating recombination and pooling of Drug substance and aseptic filling in an isolator environment.
* Perform all operational tasks related to recombination, pooling, sterile filling and visual inspection in accordance with established procedures.
* Responsible for the writing, updating and execution of Batch Records, SOPs and other GMP Documentation.
* Complete detailed batch record and GMP documentation entries which are accurate, attributable, complete, legible & clear, original, timely & prompt.
* Perform environmental monitoring and routine batch sampling per applicable SOPs.
* Perform housekeeping duties.
* Maintain an exemplary personal training record.
* Pro-actively identifies compliance risks and takes appropriate preventative actions.
* Proactively identify equipment issues and perform root cause analysis, make recommendations and aid in implementation for more complex and reoccurring issues.
* Proactively lead and support continuous improvement initiatives within the sterile filling facility.
* Provide leadership and guidance on shift to support and influence positive behaviour.
* Support investigations into Quality events, including reporting production issues, writing reports and implementing CAPAs, etc. as required.
* Participate in/Lead cross functional team initiatives.
* Participate & support site inspections by regulatory agencies.
* Demonstrate commitment to a high level of safety awareness within the sterile filling team.
* Execute all operations activities in a safe manner and in strict accordance to SOPs, cGMP regulations and site Quality standards.
* Support Sterile filling equipment commissioning and qualification.
* Interface with external vendors & service providers.
* Bachelor degree in Biotechnology, Chemical or Biochemical Engineering, Biochemistry or Bio-systems Engineering or related field or equivalent experience is preferred.