This is a 11 month contract with a view to extension
This role will involve being a part of our Automation and Process Engineering Hub for our new state of the art single use multi-product biotech facility. This facility will manufacture enzyme replacement and antibody-based therapies for a leading global biotech company focused on rare diseases. The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.
The Manufacturing Execution System Engineer will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to achieve the strategic objectives related to Safety, Quality/Compliance, Supply Assurance (i.e. capacity, yield, fulfillment), and Value.
OPERATIONAL AND TECHNICAL SUPPORT (50%)
• Provide manufacturing execution systems, automation and technical support to ensure stable, efficient and robust operations at the site.
• Maintains the plant engineering areas in an inspection-ready, GMP compliant state.
• Anticipate, solve or escalate problems as appropriate.
• Provide timely update of achievements and challenges
• Support escalation plan for routine and out of hour’s emergencies, and response for automation team.
• Work collaboratively on resolving obstacles and building relationships so as to maintain a highly effective and productive work environment.
• Investigate events and non-conformances and complete technical reports as appropriate.
SYSTEMS ENGINEERING (50%)
• Monitor and optimise systems performance
• Conduct risk assessments and mitigation projects relating to system performance.
• Collaboratively develop requirements and recommendations for system modifications, upgrades, retrofits and replacements.
• Manage manufacturing execution systems projects and maintenance programmes by following a systematic approach in accordance with financial and business requirements.
• Control, develop and modify manufacturing execution system process recipes.
• Provide appropriate support to ensure manufacturing execution system design, commissioning, qualification and validation is executed per requirements.
• Manage implementation and cost control of small to medium sized site specific projects through conception, approval, planning, execution, and validation in all parts of the plant.
• Develop and implement robust processes to drive an environment of right-first-time.
• Utilise Operational Excellence tools and techniques in completing designs, implementing technical solutions and resolving complex problems.
• Maintain specifications and standard procedures to align with industry standards.
• Establish and maintain best-in-class automation systems, process and methodologies around the management of automation specifications, GEP, reliability and technologies and the integration of a highly automated operating model across the site.
• Review and approve changes to operating procedures and the change control process relating to the systems
• Level 8 Qualification in a Science or Engineering discipline is required.
• At least 8 years’ experience in the biotechnology and/or pharmaceutical industry desirable, (preferably both).
• Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.
• Prior Manufacturing Systems experience is not considered essential for the right candidate
– bioprocess engineering, process operations experience in an automated environment etc will be considered.
• Interest in computers an advantage.
• Must enjoy working in a team-based environment.
This is a 6 month contract Purpose The MMDIT Labs CSV Engineer will be responsible for delivery of Automation and...Apply For This Job
This is a 11 month contract with a view to extension Purpose Providing coordination of the delivery of IT infrastructure...Apply For This Job
Purpose: Generate/ update, execute, review and approve Computer System Validation (CSV) documentation deliverables as part of a multi-disciplinary team of...Apply For This Job
This is a 12 month contract with a view to extension Responsibilities • Support critical-to BioPharma Automation Infrastructure and ensure...Apply For This Job
This role is an 11 Month Contract with a view to extension. Purpose To Generate & update, execute, review and...Apply For This Job