Our Clients
They are a fast-growing Contract Development and Manufacturing Organisation (CDMO) specialised in production of recombinant proteins, mRNA and plasmids and dedicated to helping their clients bridge the gap between science and manufacturing. Acting as catalysts for their research and innovation, they provide tailored solutions that empower breakthroughs in biotechnology.
Located in Barcelona, a prominent biotechnology hub, they pride ourselves on delivering exceptional client-focused services while fostering a dynamic and innovative workplace environment.
As the IT/OT Specialist, you will be responsible for overseeing all aspects of IO/OT Systems and infrastructure. Your leadership will be critical in ensuring the highest standards and availability of the IT Systems that support the activities and processes, regulatory compliance, and continuous improvement across our production lines and business.
Primary Responsibilities
- Lead ERP implementation project, ensuring compliance with company requirements.
- Design and roll a CSV plan to validate IT/OT systems and electronic documental processes in accordance with industry regulations such GxP, FDA 21 CFR Part 11, GAMP 5.
- Design, implement and manage servers in virtualised environments, guaranteeing their performance and availability.
- Manage SAS-based cloud environments and systems, ensuring effective integration with the ERP in accordance with de process and business requirements.
- Design and configure IT/OT networks using Cisco infrastructure, ensuring connectivity, availability and security of systems.
- Implement and manage security standards, including firewalls and system backups and user’s profiles definition.
- Manage internal and externals partners to support business operations.
- Provide technical support and training to users on the use of systems and IT tools.
- Collaborate with multidisciplinary teams to identify and resolve technical issues.
Requirements
- Bachelor’s degree in computer science, Systems Engineering, or a related field.
- Minimum of 5 years of experience in ERP implementation projects, preferably SAP or Microsoft Business Central.
- Experience in validating information systems in the pharmaceutical industry, with knowledge of GxP, GAMP5 and FDA 21 CFR Part 11.
- Knowledge of creating and managing servers in virtualized environments.
- Experience in managing SAS-based cloud environments and systems.
- Knowledge of designing, configuring and manage computer networks with Cisco technology.
- Experience in difine and managing security standars, firewalls, and system backups.
- Strong leadership, communication, and problem-solving skills, with a track record of effectively managing teams, budgets, and projects in a highly regulated environment.
- Ability to collaborate effectively with cross-functional teams and external clients, providing clear and expert guidance on quality-related matters.
