Position Summary
Responsible for the support, maintenance, enhancement, delivery, and lifecycle management of business-critical pharmaceutical applications and manufacturing systems within a regulated GxP environment. Serves as both a technical SME and delivery lead, ensuring operational stability, compliance, system performance, stakeholder alignment, and successful execution of technology initiatives.
Key Responsibilities
- Provide technical support, administration, configuration, and maintenance for pharmaceutical and manufacturing applications.
- Serve as the SME for assigned technologies, applications, integrations, and business processes.
- Troubleshoot complex application and integration issues, perform root cause analysis, and implement corrective actions.
- Monitor application performance, availability, and operational health.
- Lead end-to-end delivery of enhancements, upgrades, and strategic technology initiatives.
- Facilitate Agile ceremonies, backlog prioritization, sprint planning, and stakeholder reviews.
- Manage project plans, timelines, risks, issues, dependencies, and status reporting.
- Coordinate activities across development teams, infrastructure teams, vendors, managed service providers, and business partners.
- Support testing, validation, release management, deployment, and post-release stabilization activities in compliance with GxP requirements.
- Partner with Product Managers and business stakeholders to evaluate enhancements and improve user experience.
- Ensure compliance with cybersecurity, audit readiness, data retention, access control, CSV, and regulatory requirements.
- Deliver technical training, knowledge transfer, and user support.
- Support full application lifecycle management, including upgrades, patching, decommissioning, and retirement planning.
- Support resource planning, vendor oversight, and budget tracking activities.
Technical & Leadership Skills
- SAP ERP and manufacturing integrations
- Manufacturing Execution Systems (MES) such as PAS-X, Syncade, or PharmaSuite
- Application Monitoring and Operational Support
- System Integration and Middleware Technologies
- Incident, Problem, Change, Release, and Service Management
- Agile and Scrum Frameworks
- Project and Portfolio Management
- Computer System Validation (CSV) and SDLC
- Data Integrity and GxP Compliance
- Azure DevOps, Jira, and ServiceNow
- SQL and troubleshooting tools
- Risk, Issue, Dependency, Vendor, and Resource Management
- Executive Stakeholder Communication and Reporting
Required Qualifications
- 5-7+ years supporting and/or delivering enterprise technology solutions within pharmaceutical, biotech, life sciences, healthcare, or other regulated industries.
- Experience supporting validated systems within a GxP-regulated environment.
- Strong understanding of SDLC, CSV, Agile delivery, change management, and compliance processes.
- Demonstrated experience leading cross-functional teams, projects, or workstreams.
- Experience managing complex application, infrastructure, and integration-related initiatives.
- Strong analytical, problem-solving, stakeholder management, facilitation, and communication skills.
- Ability to balance technical operational support responsibilities with project delivery and strategic planning activities.