Site IT Lead (all genders)

Overview

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO). We deliver development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), mRNA, viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle; Boulder and Longmont, Colorado; Copenhagen; Heidelberg; Milan; and Chiba. We employ more than 2,500 people worldwide. Our commitment to continuous innovation fosters the technical creativity to solve clients\' challenges, including fast-track projects and rare diseases.

Site IT Lead – Heidelberg

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 information technology. The Site IT Lead understands the business requirements and technology needs for API and Biotechnological Manufacturing and is responsible for managing IT projects, supporting critical manufacturing and quality control systems, and ensuring compliance with industry regulations such as GMP. In this role you will be part of the Global IT Leadership Team reporting to the Sr. Director, IT Manufacturing.

Responsibilities

• 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 environment. 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 align local needs to global IT.
• Build and maintain a close working relationship with 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 the 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.

Qualifications

• Master\'s degree in computer science, management information systems, or equivalent work experience.
• 8+ years of IT experience, preferably in the pharmaceutical manufacturing 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 ecosystem (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.

Benefits

• 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.
• Lunch allowance 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 program.