Job Description
A fantastic and exciting opportunity has arisen for aLead Manufacturing Biotech Associateat Dunboyne Biologics.
The Lead Manufacturing Biotech Associate is a leader with strong interpersonal, communication, and collaboration skills. The Lead 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 Our Company’s requirements to ensure compliance, safety and provide a reliable supply to our customers.
Bring your energy, knowledge, and innovation to:
- Carry out and support operations to achieve assignedduties.
- Deliver shift standard work for a team-based approach to batchprogression.
- 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 validationprocesses.
- 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 todocumentation.
- Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices
- Initiate/ maintain housekeeping in all workareas.
- Identify, escalate and address compliance, environmental, safety, and process deviations asappropriate.
- 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 theyarise.
- Actively participate on cross-functional manufacturing teams to advance projects, goals anddeliverables.
- Lead approved projects and continuous improvement initiatives that are in alignment with the sitestrategies.
- Lead straight-through document accuracy metrics and the development of a CIframework.
- Support site functional initiatives to improve compliance status and operational efficiency of thesite.
- Run handover boards and provide key updates to shift leads forhandover.
- 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 areunavailable.
- 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 equipmentshutdowns.
- Ensure resources are available, thereby minimizingdowntime.
- Any other duties as and when assigned by the Manager. Such as act as a designee for Manufacturing Shift Lead as required.
What skills you will need:
- 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 GMPenvironment.
- 3 years experience in Biopharma industry, with direct experience of biologics manufacture would bedesirable.
- Proven record of accomplishments in a regulated industryrequired.
- 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 Leanmethodologies.
- Familiar with all Safety, GMP, Environmental and Validation permits, policies andprocedures.
- Familiar with plantequipment.
- Training others and/ or leading hands-on or instructor-ledtraining.
- Ability to read, write and understand technicalinformation.
- 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 underpressure.
- Excellent trouble shooting and problem-solving skills to coach and mentor the teams through complex problems solving.
- This role is a site basedposition.This role will involve working shift, on a 24/7basis
So, if you are ready to:
Current Contingent Workers apply
Not Applicable
Hazardous Material(s):
Job Posting End Date:05/17/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.