Job Summary
We are seeking an experienced professional to join our team at Claran Consultants Ltd.
The successful candidate will bring their energy, knowledge, and innovation to a multi-functional team to deliver results within schedule.
This role is responsible for leading and assisting in investigations, ensuring root cause analysis and CAPAs, data analysis and interpretation to resolve complex cell culture deviations.
In addition, the individual will lead process improvement and troubleshooting with an end-to-end product focus.
They will support the industry 4.0 initiative to navigate operations and data analytics in a digital environment.
The technical specialist will provide guidance to members of the process engineering team and IPT.
Responsibilities
* Lead and assist in investigations, ensuring root cause analysis and CAPAs;
* Conduct data analysis and interpretation to resolve complex cell culture deviations;
* Lead process improvement and troubleshooting with an end-to-end product focus;
* Support the industry 4.0 initiative to navigate operations and data analytics in a digital environment;
* Provide technical guidance to members of the process engineering team and IPT;
* Author and review batch documentation, technical reports, and supporting global regulatory submissions as needed;
* Support execution, data analysis, and interpretation of trends observed in commercial process monitoring (e.g., proactive process analysis, continued process verification, statistical process control, multivariate analyses);
* Lead and/or support various site initiatives to improve compliance status and overall operational efficiency of the site;
* Lead and/or support the execution of development and PPQ batches;
* Resolve issues and identify risks in a timely fashion;
Requirements
To excel in this role, the successful candidate will have:
* A degree (or higher) in Science, Engineering, Technical or equivalent;
* At least 6 years of operational support experience in the Biopharma industry;
* Direct experience of USP biologics manufacture, facility commissioning, qualification, validation, and start-up;
* Strong contemporary knowledge and ability to work independently and on multidisciplinary teams;
* Proven ability in collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site;
* Experience in leading complex investigations;
* Working knowledge of current regulatory requirements and current Good Manufacturing Practices;