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Job Description
Lead Biotech Associate required for a leading multi-national Biotech client in Meath, Ireland.
This is an 11-month contract shift position in a new state-of-the-art single-use multi-product biotech facility.
Job Description
The Lead Manufacturing Biotech Associate is a leader with strong interpersonal, communication, and collaboration skills.
Responsibilities include:
- Supporting the manufacturing process and creating an inclusive culture that prioritizes Safety First, Quality Always, and continuous improvement.
- Carrying out and supporting operations to achieve assigned duties.
- Delivering shift standard work for a team-based approach to batch progression.
- Conducting sampling/in-process testing supporting the manufacturing and validation processes.
- Documenting executed activities necessary to allow proper accountability and traceability of production records.
- Authoring, reviewing, and/or editing procedures and technical documents to ensure compliance with cGMP requirements.
- Providing coaching to the shift teams on the Right First Time (RFT) approach to documentation.
- Ensuring all assigned tasks related to manufacturing documentation support are in accordance with good manufacturing practices.
- Initiating/maintaining housekeeping in all work areas.
- Identifying, escalating, and addressing compliance, environmental, safety, and process deviations as appropriate.
- Supporting the execution of safety walkdowns, audits/inspections, risk assessment, and implementation of agreed-upon actions.
- Ensuring incident investigations are fully supported with improvement actions implemented and participating in investigations arising from manufacturing documentation aspects.
- Coaching and providing oversight on the shop floor to identify potential issues before they arise.
- Actively participating on cross-functional manufacturing teams to advance projects, goals, and deliverables.
- Leading approved projects and continuous improvement initiatives that align with the site strategies.
- Leading straight-through document accuracy metrics and the development of a CI framework.
- Supporting site functional initiatives to improve compliance status and operational efficiency of the site.
- Running handover boards and providing key updates to shift leads for handover.
- Being the escalation point of contact (POC) for troubleshooting, supporting task execution, problem-solving, CI projects, and assisting with the resolution of issues/delays.
- Taking ownership of activities within a suite and acting as a delegate for the shift lead if they are unavailable.
- Ensuring process equipment is maintained, including preventative maintenance, equipment troubleshooting, and repairs to ensure continuous, reliable, and repeatable operation of equipment.
- Effectively managing and scheduling equipment shutdowns.
- Ensuring resources are available, thereby minimizing downtime.
Requirements
- Minimum of a Bachelor's Level 8 degree in Science, Engineering, or other Technical Discipline or a Level 7 qualification in a science or engineering discipline with a minimum of 5 years industry experience.
- 5 years of experience in a GMP environment.
- 3 years of experience in the Biopharma industry, with direct experience of biologics manufacture.
- Proven record of accomplishments in a regulated industry required.