Electrical Asset Engineer required for a fantastic Biotech (Gene Therapy) company in Central London who specialise in developing potentially curative treatments for patients living with serious diseases.
They currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Their initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy can provide meaningful clinical benefit in these areas.
The site in London is a state-of-the-art manufacturing facility which was designed to meet global regulatory requirements. The 29,000-square foot facility has the flexibility and capacity to produce sufficient products for all their clinical trials and will scale to commercial capacity.
The Electrical Asset Engineer will support setting up their internal Manufacturing Facility for the manufacture of Advanced Therapies (Gene Therapy viral vectors). The facility is planned to manufacture Phase 1 and 2 clinical material with the ambition to make Phase 3 and commercial supply for its in-house programmes. The facility requires a multi-skilled asset engineer with electrical experience to assist the Engineering Asset Manager with the co-ordination of the day to day asset care and facility requirements and performance improvements, across the site.
Responsibilities for the Electrical Asset Engineer will include:
Oversee service contractor activities for PPM and reactive maintenance.
Assist with the continuous development and implementation of the internal and external PPM schedule, and ensuring adherence to it.
Carry out PPM and reactive maintenance as required.
Lead/assist with quality investigations in compliance with their Quality Management System.
Maintain all current statutory, regulatory and company safety and quality standards.
Assist with the implementation, maintenance and measurement of a framework for compliance and ongoing improvement in quality performance and right first time culture within the facilities and engineering area. This will be in accordance with statutory, regulatory and company standards, procedures and systems regarding relevant cGMP, Quality Systems and Health and Safety in the workplace.
Ensure the availability and reliability of building utilities, services and manufacturing equipment for the operational areas, in order that they can achieve the plans to satisfy customer requirements.
Develop and manage strong relationships across teams to remove barriers and time lags.
Assist with the identification and implementation of technology based and working practice solutions designed to reduce the overall cost per unit measures.
Preparation of and input into equipment and System URS, Design Qualifications, Data Integrity assessments to ensure that Equipment and Systems meet user and Qualification requirements.
Assist with the qualification/validation introduction of new equipment
Assist with the development and maintenance of the engineering budget and critical spares stocklist.
Oversee the daily duties of the Junior Asset Engineer and assist with the development of the Junior Asset Engineer.
Deputise for the Engineering Asset Manager where required.
Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken
Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state
It is essential the candidate has the following background:
Comprehensive practical and theoretical background on a wide range of industrial plant and cleanroom services and utility equipment.
Proven experience in implementing engineering techniques - typically compressed air, H.V.A.C. systems applied to both general industrial and cleanroom standards
Experience of working within a cleanroom environment.