Site IT Lead (all genders)

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients\‘ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice.

Site IT Lead (all genders)

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients\‘ lives by bringing new biopharmaceuticals to market.

JOB SUMMARY

The Site IT Lead for our Heidelberg site acts as the subject matter expert and single point of contact to the plant business leadership team regarding any topic as it pertains to information technology. The Site IT Lead understands the business requirements and technology needs for API (Active Pharmaceutical Ingredient) & Biotechnological Manufacturing and is responsible for managing IT projects, supporting critical manufacturing and quality control systems, and ensuring compliance with industry regulations like GMP (Good Manufacturing Practice). In this role you will be part of the Global IT Leadership Team reporting to the Sr. Director, IT Manufacturing.

• Maintain close relationships with Heidelberg site leadership team and other business partners to understand site technology needs and support requirements across the site.
• Ensure site IT infrastructure lifecycle management and align to capacity growth proactively with accurate forecasts.
• Planning, implementation, and management of local IT projects, as well as leading and participating in global projects (e.g. LIMS, ERP, IT infrastructure projects).
• Support validation and qualification of IT systems in compliance with GMP requirements.
• Work closely with manufacturing, operations technology, and quality to maintain and manage a compliant GxP environments. Review multiple team, group, or service deliverables to ensure quality (design walk-through, test results, etc.) and adherence to processes, standards, and regulatory requirements. Participate in all internal and external audits and provide services in a timely manner.
• Participate on the global IT leadership team as a strategic partner in developing a world-class global IT organization.
• Communicate IT strategies and roadmaps to site leadership and local needs to global IT.
• Build and maintain a close working relationship with the internal peers and the larger IT organization to provide services around networks, hosting, process control, monitoring, and IT security.
• Manage our external partner for IT services and vendor relationships.
• Responsible for managing the local escalation process of problems to appropriate support personnel. Evaluate business needs and alignment of work environment for possible process improvements and implement accordingly.
• Maintenance of ITIL methodologies (incident, problem, change, configuration, release, capacity-management) in the ITSM platform, ServiceNow.

• Master\’s degree in computer science, management information systems, or equivalent work experience.
• 8+ years of IT experience, preferably experience in (pharmaceutical) manufactory industry, at least a mid-size plant required.
• Broad understanding of systems operations, systems management, user support and help desk methodologies.
• Experience with laboratory, production, and utility systems (operational technology systems).
• Very good knowledge of Microsoft eco-system (O365, Hyper-V)
• Experience in analysis, implementation and evaluation of IT systems and their specifications.
• GxP experience is required.
• Sound administration and interpersonal skills. Must be able to interact in a team environment.
• Strong analytical and problem-solving skills.
• Strong verbal and written communication skills in German and English language.

• A modern working environment with exciting tasks in a future-oriented industry
• Experienced colleagues support you during the induction
• Working in an intercultural and international team with short communication channels across national borders
• A corporate culture characterized by openness and appreciation
• Regular company events
• Capital-forming benefits
• Jobticket
• Employer allowance for lunch with Lunch-It
• JobRad (bike leasing)
• Flexible working hours through a modern time recording system
• Free drinks (water, soft drinks, tea, coffee) and fruits
• Annual bonus programme