Lead Bioprocess Specialist (Manufacturing-Shift)

Summary:
Our client, a bio pharmaceutical company in Meath, is looking for a Lead Bioprocess Specialist to work on a 24/7 shift pattern. The successful candidate will conduct sampling/ in-process testing supporting the manufacturing and validation processes.

Responsibilities:

• Carry out and support operations to achieve assigned duties.
• Deliver shift standard work for a team-based approach to batch progression.
  Document executed activities necessary to allow proper accountability and traceability of production records, Right First Time (RFT).
• Author, review, and/or edit procedures and technical documents to ensure the documents are in accordance with cGMP requirements.
• Provide coaching to the shift teams on the RFT approach to documentation.
• Initiate/ maintain housekeeping in all work areas.
• Identify, escalate and address compliance, environmental, safety, and process deviations as appropriate.
• Support execution of safety walkdowns, audits/ inspections, risk assessment, implementation of agreed upon actions, etc.
• Ensure incident investigations are fully supported with improvement actions implemented and participate in investigations arising from manufacturing documentation aspects as and when required.
• Coach and provide oversight on the shop floor to identify potential issues before they arise.
• Actively participate on cross-functional manufacturing teams to advance projects, goals and deliverables.
• Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies.
• Lead straight-through document accuracy metrics and the development of a CI framework.
• Support site functional initiatives to improve compliance status and operational efficiency of the site.
• Run handover boards and provide key updates to shift leads for handover.
• Be escalation point of contact (POC) for troubleshooting, supporting task execution, problem solving, CI projects and assist with the resolution of issues/ delays.
• Take ownership of activities within a suite and act as a delegate for the shift lead if they are unavailable.
• Ensure process equipment is maintained including preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of equipment.
• Effectively manage and schedule equipment shutdowns.
• Ensure resources are available, thereby minimizing downtime.

Qualifications & Experience:

• Minimum of a Bachelors Level 8 degree in Science, Engineering or other Technical Discipline.
• 5 years’ experience in a GMP environment.
• 3 years’ experience in Biopharma industry, with direct experience of biologics manufacture.
• On-the-floor current Good Manufacturing Practice (cGMP) manufacturing and familiarity with regulatory requirements.
• Proficiency with automated systems such as Manufacturing Execution System (MES – PAS X), Systems Applications and Products (SAP), Delta V etc.
• Knowledge of Lean methodologies.
• Familiar with all Safety, GMP, Environmental and Validation permits, policies and procedures.
• Familiar with plant equipment.
• Training others and/ or leading hands-on or instructor-led training.