Manufacturing Biotech Associate

Manufacturing Biotech Associate

Job Purpose

This role will be part of Manufacturing Self Directed work team/ Hub in the new state of the art single use multi-product biotech facility, County Meath, Ireland. The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.

The Manufacturing Biotech Associate is a leader with strong interpersonal, communication, and collaboration skills. The Manufacturing Biotech Associate is responsible for supporting the manufacturing process, while creating an inclusive culture that energizes a Safety First, Quality Always, with a continuous improvement mindset.

Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and provide a reliable supply to our customers.

Key Accountabilities

Primary responsibilities include but not limited to:

• Carry out and support operations to achieve assigned duties.
• Deliver shift standard work for a team-based approach to batch progression.
• Complete COMMIT cards to highlight ways of working within our SDWT‘s and Hubs and across our site that support our COMMIT culture.
• Conduct sampling/ in-process testing supporting the manufacturing and validation processes.
• 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.
• Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices.
• 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.
• Approved projects and continuous improvement initiatives that are in alignment with the site strategies.
• 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

Educational and Experience Requirements

General Competencies:

• Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of Good Manufacturing Practices.
• Ability to effectively coach new trainees to build their skills so that they may become effective operations technicians and subject matter experts.
• Ability to think logically and be proactive under pressure.
• Excellent trouble shooting and problem-solving skills to coach and mentor the teams through complex problems solving.

Technical:

• 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.
• Ability to read, write and understand technical information.

Minimum Education/ Experience:

• Bachelors 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‘ experience in a GMP regulated environment.
• 5 years experience in a regulated GMP environment.
• 3 years experience in Biopharma industry, with direct experience of biologics manufacture would be desirable.
• Proven record of accomplishments in a regulated industry required

Other Job Requirements

• This role is a site based position.
• This role will involve working shift, on a 24/7 basis.