Biotechnician

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud -based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

PSC is hiring a Biotechnician in Cork, Ireland.

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.

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.