Senior GMP Applications Administrator

Partner Therapeutics•Lynnwood, WA

6d•$120,000 - $145,000

About The Position

The Senior GMP Applications Administrator is a technical partner responsible for reliable, compliant use of critical business and laboratory systems in a regulated biopharmaceutical manufacturing environment. The role combines application and database expertise with knowledge of cGMP operations, data integrity, and computerized system requirements. Working with IT, Quality, Manufacturing, Engineering, Validation, external partners, and business users, the administrator supports technology solutions that meet operational needs and regulatory expectations while advancing continuous improvement. The position administers and optimizes enterprise and laboratory applications, including Maximo, NuGenesis, MODA, and Empower; supports databases, integrations, access controls, system upgrades, and validated system status; and partners with Quality and Validation on computer system validation and lifecycle management. It also develops and maintains controlled documentation, participates in quality-system activities, coordinates with vendors, and leads or supports application projects from requirements through deployment and ongoing support. The administrator provides technical guidance and training, manages competing priorities independently, escalates stalled issues, and applies industry learning and best practices to improve systems and processes.

Requirements

Bachelor's degree in Information Technology, Computer Science, Information Systems, or a general degree with equivalent relevant experience.
At least 8 years of progressively responsible relevant experience supporting applications and database systems as an administrator or in a similar role.
Experience administering and supporting enterprise or laboratory applications.
Strong knowledge of enterprise and laboratory application administration in cGMP-regulated pharmaceutical, biotechnology, or similar environments.
Hands-on experience supporting one or more of Maximo, NuGenesis, MODA, or Empower.
Experience supporting application installations, configurations, patches, upgrades, migrations, and enhancements.
Knowledge of computer system validation (CSV) and application lifecycle management principles.
Understanding of data integrity, security, user-access management, audit trails, and electronic records requirements.
Working knowledge of relational databases and core database concepts.
Experience working with databases and application integrations.
Experience developing, revising, and following SOPs and controlled documentation processes.
Strong critical thinking, analytical, and problem-solving skills, with the ability to develop practical solutions.
Resourcefulness and ability to build and use networks of internal stakeholders, team members, and external resources to plan work and resolve issues.
Strong relationship-management and interpersonal skills, with the ability to earn others' trust and confidence.
Solid organizational and prioritization skills, with the ability to manage competing demands and deliver high-quality work on time and within budget.
Adaptability, constructive attitude, openness to feedback, and ability to work effectively across diverse teams and functions.
Excellent written and verbal English communication skills, including drafting clear communications and contributing confidently in cross-functional meetings.
Proficiency in Microsoft Office, particularly Word and Excel, and willingness and ability to quickly learn job-specific applications.

Nice To Haves

Experience with Smartsheet, MS Project, and SharePoint.
Project management experience or formal training such as PMP or PMI.
Experience in a biotechnology, pharmaceutical, or cGMP manufacturing environment.
Direct experience administering Maximo, NuGenesis, MODA, and/or Empower.
Experience supporting validated GxP computerized systems.
Knowledge of 21 CFR Part 11, data integrity principles, and computer system validation practices.

Responsibilities

Administer, maintain, support, and optimize enterprise and laboratory applications, including Maximo, NuGenesis, MODA, and Empower.
Serve as a technical subject matter expert and primary IT resource for assigned applications.
Monitor application performance, availability, integrations, and system health, and proactively address potential issues.
Support enhancements, reports, configuration changes, patches, data migrations, and system implementations.
Troubleshoot application, database, interface, configuration, and user-access issues with internal teams and external vendors.
Plan and execute system upgrades while minimizing operational disruption and maintaining validated system status.
Support database administration, including queries, troubleshooting, interfaces, backups, and data integrity.
Protect the integrity, security, availability, and appropriate access control of regulated application data.
Partner with Quality and Validation teams on computer system validation and lifecycle management.
Develop, revise, review, and maintain SOPs, work instructions, system and configuration documentation, and technical procedures.
Participate in change controls and other quality-system activities associated with computerized systems.
Maintain assigned systems in accordance with cGMP, data-integrity principles, company policies, and applicable regulatory requirements.
Collaborate with laboratory, manufacturing, engineering, quality, and business users to understand requirements and recommend technical solutions.
Coordinate with software vendors and service providers to resolve issues, implement enhancements, and support application lifecycle activities.
Lead or support IT projects from requirements gathering and system design through implementation, validation, deployment, and ongoing support.
Identify opportunities to improve application performance, reliability, usability, and business processes.
Maintain accurate application inventories, system configurations, access documentation, and lifecycle records.
Provide technical guidance and training to end users and IT team members as needed.
Manage multiple priorities independently in a fast-paced regulated environment and escalate stalled issues to Leadership and cross-functional teams in a timely manner.
Apply lessons from issues to lead creation or updates of systems, processes, and programs that prevent recurrence.
Stay current on industry trends, compliance requirements, and technologies through self-education and professional participation, and apply best practices and benchmarking to projects and solutions.
Participate in or lead collateral project teams as available to support personal growth, connection, and business needs.
Comply with internal SOPs, regulatory requirements, company policies, and employment-related laws and statutes.
Complete mandatory Compliance and Quality training within required timeframes.