Biotechnician

PE Global; Little Island; Sur place; EUR 30 000 - 50 000; Plein temps

Résumé du poste

PE Global is recruiting a Biotechnician for a leading multinational Biotech client in Cork. This is a 12-month contract on a 3-shift rotation, focusing on cleanroom operations, recombination, pooling, sterile filling, and GMP documentation.

The role requires a Bachelor's in biotech/chemistry/biology/pharmacy/engineering with 1–3 years in biotech and experience in GMP, QC, and compliance. Visa sponsorship is not provided; Irish work eligibility is required.

Qualifications

• Bachelor’s degree in biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
• 1–3 years + biotech industry experience.
• Competent in troubleshooting and practical problem-solving.
• 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 with Single-Use technologies in a manufacturing environment.
• Problem, deviation, and change management experience.
• Commissioning and qualification experience.

Responsabilités

• Demonstrate technical knowledge in cleanroom operations including recombination, pooling, and aseptic filling in an isolator environment.
• Perform operational tasks related to recombination, pooling, sterile filling and visual inspection per SOPs.

Connaissances

Biotech knowledge

GMP experience

Troubleshooting

Cross-functional teamwork

Formation

Bachelor’s degree in biotechnology, chemistry, biology, pharmacy, or process engineering

Outils

Emerson DeltaV

PAS X

Description du poste

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