Work Schedule Other Environmental Conditions Office Job Description About us Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion.
Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them!
Our team of more than 125,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Position Summary: The Brisbane, Drug Substance Division is one of five divisions that make up the Pharma Services Group (PSG).
At the Brisbane site we specialize in GMP clinical and commercial manufacturing of large molecule biologics including for clinical Phase I, II, and III, applying powerful single use bioreactors and biologics technologies.
This allows us to serve the needs of Small/Emerging, Mid-Sized, and Large Pharma sectors globally.
The network of Patheon's drug substance manufacturing sites include St. Louis, USA, Groningen, Netherlands and Brisbane, Australia.
Our Brisbane site is rapidly growing, and this role of Operations Training Specialist aims to support the growth of the Operations group.
In this role, you will be involved in onboarding and training of new Operations staff as well as training of established staff, and primarily provide subject matter expertise troubleshooting/oversights, and supporting operational reliability improvement projects.
Key Responsibilities: Work safely in accordance with EHS guidelines and adhere to Patheon cGMP Quality Management System requirements.
Become a subject matter expert, remains trained and qualified in area of expertise, and displays initiative in personal development opportunities to further enhance skills and expertise relevant to the position.
Provide SME troubleshooting/oversight and support execution of the batch as needed to deliver the site key performance indicators of Right First Time and On Time Delivery.
Establish and maintain the training programs.
Build partnerships and work collaboratively with others to develop trainee-focused content to improve operational success and sustainability.
Train both new hires and established employees.
Displays positive behaviors using the 4i values and instills this behavior throughout the training & development of staffs.
Track and trend the qualified status of Operations staffs to maintain training compliance.
Write and update standard operating procedures and work instructions for processes using the Electronic Document Management System.
Assists Operations group with deviation investigation and determination/implementation of preventative/corrective actions.
Devises PPI initiatives to drive continuous improvement in Operations.
Skills and Attributes: Must have significant cGMP experience and technical knowledge in Media and Buffer preparation process.
Excellent written & verbal communication skills.
Ability to work under pressure on multiple tasks and manage conflicting priorities independently.
Possess strong organizational skills and a dedication to excellence.
Preference for a Degree level in Biology, Chemistry or related field or related work experience.
Sufficient knowledge of Microsoft packages i.e.
Word, Excel, PowerPoint, Microsoft Teams.
Experience using SFLMS, eDMS, Trackwise, SAP.
Employee Benefits: A competitive salary and performance related bonus structure Access to Thermo Fisher's global University Exposure to market leading & innovative technologies Career development opportunities in a leading global organization We offer competitive compensation and benefits packages, along with opportunities for professional growth and development.
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