Join Us in Bringing Hope to Life
Our purpose is to bring hope to life by enabling life‑changing therapies for patients around the globe, creating a healthier and happier tomorrow. To advance this purpose, we rely on team members who value excellence, collaboration, and meaningful work. If this resonates with you, we invite you to explore the role further and apply.
Job Summary
We are seeking a TrackWise Digital Administrator to support and maintain the TrackWise Digital (TWD) system in alignment with business and compliance requirements. This role serves as the primary point of contact for system administration and first‑level support, ensuring system performance, stability, and usability.
About the IT Systems Team
You will join a Global IT Systems team responsible for supporting validated systems that enable quality and compliance processes across the organization. The team partners closely with QA, Operations, and IT Security to ensure systems remain reliable, compliant, and aligned with business needs.
Key Responsibilities
Provide day‑to‑day administration and support of the TrackWise Digital system.
Serve as first‑level support for end users, including troubleshooting and training support.
Manage user access, including provisioning, updates, and periodic reviews.
Maintain system uptime, backups, and restore processes.
Manage system roadmap activities, including releases, upgrades, and enhancements.
Partner with business stakeholders to gather and meet system requirements.
Collaborate with IT Security to ensure alignment with security standards.
Own system lifecycle activities, including:
Change control (releases, bug fixes, updates)
Technical requirements and design/configuration specifications
Installation and operational qualification (IQ/OQ) testing and defect management
Requirements traceability
Administration SOP development
Support and review validation documentation, including validation plans, UAT, summary reports, and periodic reviews.
Support data migration and system decommissioning activities as needed.
Work with internal teams and external vendors to resolve issues and maintain system performance.
Skills
Strong written and verbal communication skills.
Project management and organizational skills.
Analytical and problem‑solving capability.
Ability to manage multiple priorities in a team‑based and independent environment.
Qualifications & Experience
Required:
2–4 years of TrackWise Digital or Salesforce experience (configuration, validation, implementation, or administration).
Experience with Salesforce tools (e.g., SOQL, Flows, troubleshooting).
Familiarity with GMP and validated systems environments.
Proficiency in Windows operating systems.
Strong communication skills and ability to work both independently and in teams.
Preferred:
Experience implementing or upgrading regulated systems.
4–6 years of experience in computer system validation or related areas.
Demonstrated experience driving process improvements or system efficiencies.
Formalities
Location: Bothell, Washington
Compensation Range: $83,920 - $115,390
Who We Are
AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in the United States. From our headquarters in Bothell, Washington, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
We are a collaborative, inclusive, and equal‑opportunity organization where team members are valued for their expertise, teamwork, and ingenuity.
Skills Required
- 2-4 years of TrackWise Digital or Salesforce experience (configuration, validation, implementation, or administration)
- Experience with Salesforce tools (SOQL, Flows, troubleshooting)
- Familiarity with GMP and validated systems environments
- Proficiency in Windows operating systems
- Strong written and verbal communication skills
- Ability to work independently and in teams
- Project management and organizational skills
- Experience implementing or upgrading regulated systems
- 4-6 years of experience in computer system validation or related areas
- Demonstrated experience driving process improvements or system efficiencies
What We Do
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics (using mammalian and microbial systems), mRNA, pDNA, viral vector and cell therapy products, from pre-clinical to commercial production, including our proprietary CHEF1TM Expression System for efficient protein production with CHO cells. Our company DNA drives us to provide innovative solutions to partner with our customers in helping them reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle. We forge exceptionally strong partnerships with our customers and we never lose sight of our commitment to deliver reliable and compliant drug substance. Visit www.agcbio.com to learn more.
