Senior GMP Applications Administrator
New
P
Partner TherapeuticsBiopharmaceutical manufacturing
United StatesFull-TimeSenior
SalaryThe current pay range for this position is $120,000 - $145,000
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Job Details
- Languages
- Excellent written and verbal English communication skills.
- Experience
- 8+ years of progressively responsible, relevant experience supporting applications and database system as an administrator or in a similar role.
- Required Skills
- Microsoft Office
Requirements
- Hold a bachelor's degree in Information Technology, Computer Science, Information Systems, or have equivalent relevant experience.
- Have 8+ years of progressively responsible experience supporting applications and database systems as an administrator or in a similar role.
- Have strong knowledge of enterprise and laboratory application administration in cGMP-regulated pharmaceutical, biotechnology, or similar environments.
- Have hands-on experience supporting one or more of Maximo, NuGenesis, MODA, or Empower.
- Have experience with application installations, configurations, patches, upgrades, migrations, and enhancements.
- Know computer system validation (CSV) and application lifecycle management principles.
- Understand data integrity, security, user-access management, audit trails, and electronic records requirements.
- Have working knowledge of relational databases and experience with application integrations.
- Have experience developing, revising, and following SOPs and controlled documentation processes.
- Be proficient in Microsoft Office, particularly Word and Excel.
- Have excellent written and verbal English communication skills.
- Preferred: experience with Smartsheet, MS Project, and SharePoint.
- Preferred: project management experience or formal training such as PMP or PMI.
Responsibilities
- Administer, maintain, support, and optimize enterprise and laboratory applications, including Maximo, NuGenesis, MODA, and Empower.
- Monitor application performance, availability, integrations, and system health, and address potential issues.
- Support enhancements, reports, configuration changes, patches, migrations, implementations, and system upgrades.
- Troubleshoot application, database, interface, configuration, and user-access issues with internal teams and external vendors.
- Support database administration, including queries, interfaces, backups, and data integrity.
- Partner with Quality and Validation teams on computer system validation and lifecycle management.
- Maintain application procedures, SOPs, work instructions, technical documentation, configuration records, inventories, and lifecycle records.
- Lead or support IT projects from requirements gathering and system design through implementation, validation, deployment, and ongoing support.
- Collaborate with business and technical teams to understand system requirements and recommend solutions.
- Provide technical guidance and training to end users and IT team members.
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