Biotechnician

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

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland