- We are looking for a Lead Manufacturing Biotech Associate to join our client’s new state of the art biopharmaceutical facility in Co. Meath. This role will be part of a Manufacturing Self Directed work team/ Hub.
- 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 Lead Manufacturing Biotech Associate is a leader with strong interpersonal, communication, and collaboration skills.
- The successful candidate 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 site requirements to ensure compliance, safety and provide a reliable supply to customers.
- This role is a site-based position.
- This role will involve working shift, on a 24/7 basis.
Core Duties and Responsibilities:
- 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.
- 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.
- Any other duties as and when assigned by the Manager.
Minimum Qualifications and 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.
- Proven record of accomplishments in a regulated industry required
- 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.
- 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.
To Apply: Quote – PE22108
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.