Senior Maintenance Engineer

8 hours ago


Cowley, United Kingdom Oxford BioMedica Limited Full time

Company description: Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world.Read on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application.One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patients cells.One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients cells.This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors.Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation.These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.Job description: Join Us in Changing Lives At OXB , our people are at the heart of everything we do.Were on a mission to enable life-changing therapies to reach patients around the worldand were looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful .Were currently recruiting for a Senior Maintenance Engineer for the Engineering team.In this role, you will utilize Good Engineering Practices (GEP) to establish and maintain the industrial process automation, building automation and operational technology systems required to support cGMP manufacturing and process development.As a system owner, you will be responsible for day-to-day operations support and troubleshooting, project execution, commissioning and qualification support, and optimizing process and utilities equipment within a regulated cGMP facility, playing a key part in advancing our mission and making a real difference.Your responsibilities in this role would be: Assuming ownership responsibility of control systems and other operational technologies by applying the engineering lifecycle to enable cGMP manufacturing.Organizing and leading all aspects of cross-functional internal projects including scope, schedules, and execution.Applying technical expertise in ensuring the reliability of complex process equipment, data, and building and utilities systems.Developing solutions and best practices for a variety of problems with moderate scope and complexity, and working collaboratively with Quality, Manufacturing, Facilities, Process Development, external supply partners, and vendors.Responding to support calls and troubleshoots equipment and uses evaluation, judgement, and interpretation to resolve issues and select best course of action.Being a Control Systems Engineering representative for capital projects involving building automation, process and utilities equipment for cGMP facilities.Profile description: We are looking for: Technical/ Complex equipment systems Control systems.Bioreactor/ Filling line background.Background in GMP/ Pharma/ regulated environments: Bachelor's degree in Electrical Engineering / Computer Science / Chemical Engineering or equivalent, with a minimum of 5 years of experience in a cGMP engineering environment, or advanced degree in lieu of experience.Significant knowledge and understanding of GMP engineering principles and practices in the gene therapy industry.Manufacturing control systems automation background focused specifically in the design, installation, programming, validation, and in lifecycle maintenance of automated equipment, specifically in a GMP environment.Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, and 21 CFR Part 11.Demonstrated experience with network architecture including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration, and Firewalls.Able to accommodate changing priorities and deadlines and work independently solving complex process and equipment problems.We offer: Why Join Us? Competitive total reward packages Wellbeing programmesthat support your mental and physical health Career development opportunitiesto help you grow and thrive Supportive, inclusive, and collaborative culture State-of-the-art labs and manufacturing facilities A company that lives its values: Responsible, Responsive, Resilient, Respect We want you to feel inspired every day.At OXB, were future-focused and growing fast.We succeed togetherthrough passion, commitment, and teamwork.Ready to Make a Difference? Collaborate.Contribute. xpwpeyx Change lives.



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