Process Improvement Specialist

6 days ago

Brisbane, Queensland, Australia beBeeExpert Full time $100,000 - $150,000
Job Title

Bioprocess Specialist

Job Description

As a key member of our team, you will discover meaningful work that makes a positive impact on a global scale. You will work safely in accordance with EHS guidelines and adhere to Quality Management System requirements.

Responsibilities:

  • Act as a subject matter expert (SME), remain trained and qualified in area of expertise, and display initiative in personal development opportunities to further improve skills and expertise relevant to the position.
  • Provide expert troubleshooting/oversight and support execution of the batch as needed to deliver site key performance indicators of Right First Time and On Time Delivery.
  • Build partnerships and work in collaboration with Operations Managers in mentoring Operations staffs with a focus on building talent depth and demonstrating positive behaviors that align with 4i values.
  • Support operational production and facility maintenance planning as well as the transfer of new technologies/procedures/equipment to Operations to address production demands as per S&OP and MPS.
  • Review and approve manufacturing batch records, standard operating procedures, logbooks, or validation protocols required for Phase III projects as per ICH guidelines.
  • Collaborate with the Operations team to investigate deviations and determine/implement preventive/corrective actions.
  • Ensure audit readiness within Operations by identifying and addressing gaps as well as preparing storyboards and provide expert input during audits.
  • Devise Process Improvement initiatives to drive continuous improvement in Operations.
Required Skills and Qualifications

Must have significant experience and technical expertise in Cell Culture, Harvest Operations, or Downstream Processing.

Have excellent written & verbal communication skills.

Able to work independently on multiple tasks and balance priorities under pressure.

Possess strong interpersonal and planning skills with dedication to excellence.

Preferred to be educated to minimum degree level in Biology, Chemistry or related field.

Proficiency with Microsoft packages i.e. Word, Excel, PowerPoint, Teams.

Experience with SFLMS, eDMS, Trackwise, or SAP is a plus.

Benefits

Join us and take advantage of these great benefits.

  • Health & Wellbeing: Join a company that prioritizes health & wellbeing with comprehensive benefits, wellness programs, and Employee Assistance Program providing confidential support for personal and work-related issues.
  • Flexibility: Balance your work and personal life with flexible arrangements.
  • Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
  • Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations.
  • Learning & Development: Advance your career with access to online courses via University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

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