PE Global is currently recruiting for a Biotechnician for a leading multi-national Biotech client based in Cork.
This is an initial 12-month contract position working on a 3-cycle shift.
ROLE:
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 behaviours.
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.
REQUIREMENTS:
Bachelor's degree in biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
1-3 years + Biotech Industry (bulk manufacturing of pharmaceutical or biological components)
Competent in troubleshooting and show practical problem-solving capabilities.
Ability to work independently and within a cross-functional team.
Understanding of multi column chromatography concepts
Familiarity with contamination control and batch release requirements
Familiarity with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing Process.
Proficiency in various SingleUse technologies in a manufacturing environment
Problem, Deviation, and Change Management experience
Commissioning and Qualification experience
Interested candidates should submit an updated CV.
Please click the link below to apply, call Seán on *************** or alternatively send an up-to-date CV to ******
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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