Description:
The BTA plays a critical role in supporting safe, compliant, and efficient biologics manufacturing. They execute automated, paperless manufacturing processes across cell culture, filtration, and purification activities using state-of-the-art single-use technology. Working on a designated shift, they set up equipment, run production operations to world-class GMP and EHS standards, and contribute to continuous improvement through standard work and lean practices. This role is central to delivering high-quality drug substance to patients.
Responsibilities:
- Support operations team to consistently deliver on specific Key Performance Indicators (KPIs), e.g. Environmental Health and Safety (EHS) metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance and team training.
- Complete COMMIT cards to highlight ways of working within our SDWT's and Hubs and across our site that support our COMMIT culture.
- Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts.
- Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).
- Ensures that all assigned task related to manufacturing documentation support is in accordance with good manufacturing practices.
- Routinely talk about any safety issues you are concerned about.
- Work as part of a dedicated proess team where flexibility and teamwork are a key requirement.
- Generate SOPs/ Work Instructions (WIs) to ensure compliance with regulatory standards.
- Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
- Escalate issues as appropriate to manager/designee.
- Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.
- Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan and site schedule.
- Challenge and identify improvements to the safety and environmental programmes on site.
- Celebrate with use of proactive recognition tools that inspire teams and individuals you collaborate with.
- Take part in shift handovers and tier 1 meetings, raising concerns or issues promptly and providing options for resolutions.
- Act as an ERT during emergency situation if trained .
- Maintain/ support a high standard of safety/ Good Manufacturing Practice (GMP) compliance at all times.
- Determine solutions by referencing relevant past experiences as part of problem solving activities.
- Get actively involved by participating in inspections, GEMBA's and Go-See's.
- Act as a team member on process deviation reviews and Gemba walkdowns.
- Be prepared to answer auditor questions during site walkdowns.
- Engage in implementing innovative solutions that drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals.
- Utilize Lean Six Sigma Tools to support the initiative of continuous improvement (CI) projects to increase agility, flow, throughout and reduce cycle time and inventory.