Application System Administrator - W2 Only - Local/Hybrid - BB10124

Application System Administrator - W2 Only – Local/Hybrid – BB10124

BB10124

Lexington, MA

6+ Months

1. Services Overview / Objective

The purpose of this Statement of Work (“SOW”) is to engage a contractor to provide application system administration services in support of manufacturing, laboratory, and automation systems.

The contractor shall ensure that all supported systems are maintained in a reliable, compliant, secure, and inspection-ready state, in accordance with site procedures, regulatory requirements, and applicable quality standards.

2. Scope of Services

The Contractor shall provide application system administration and operational support services, including, but not limited to, the following:

2.1 System Administration and Maintenance

·

· Maintain systems in a qualified and validated state

· Execute system maintenance activities, including patch coordination, system health checks, and backups

· Ensure systems remain in a secure and controlled state with appropriate documentation and governance

2.2 User Access and Security

· Administer user accounts, roles, and permissions in accordance with site procedures

· Support periodic access reviews and audit activities

· Investigate and resolve access-related issues (e.g., account lockouts)

· Ensure compliance with data integrity and security requirements

2.3 Monitoring and Incident Management

· Monitor system performance, alerts, and availability

· Respond to and troubleshoot system incidents and user-reported issues

· Escalate critical issues in accordance with site procedures

· Support root cause investigations and deviation/CAPA activities

2.4 Change and Configuration Management

· Execute system changes in accordance with approved change management processes

· Maintain configuration documentation and system inventories

· Support lifecycle activities including upgrades, patching, enhancements, and decommissioning

2.5 Backup, Recovery, and Continuity

· Ensure backup processes are operational, monitored, and validated

· Support periodic backup verification and disaster recovery testing

· Maintain documentation of recovery procedures

2.6 Documentation and Compliance

· Maintain system administration logs and records of activities

· Ensure documentation is complete, current, and audit-ready

· Contribute to SOPs, Work Instructions, and system administration playbooks as required

· Ensure compliance with data integrity, regulatory, and site quality requirements

2.7 Periodic Review and System Health Checks

· Perform periodic system reviews, including but not limited to:

o User account reviews

o Audit trail reviews

o Antivirus and system logs

o Server and application performance monitoring

· Verify system functionality and identify continuous improvement opportunities

· Ensure no outstanding critical system issues remain unresolved

2.8 Cross-Functional Support

· Collaborate with Automation Engineering, IT, Quality, and Operations teams

· Provide technical support during manufacturing operations as required

3. Deliverables

The Contractor shall provide the following deliverables:

· System administration activity logs

· Periodic system review and health check reports

· Incident and issue resolution documentation

· Updated system documentation (configurations, procedures, inventories)

· Backup and recovery verification records

· Audit and inspection support materials

4. Key Performance Indicators (KPIs)

The Contractor’s performance shall be measured against the following key performance indicators:

· System uptime and availability targets (as defined by site criticality)

· Timely response and resolution of incidents in accordance with agreed SLA timelines

· Completion of periodic system reviews on schedule

· Compliance metrics, including documentation completeness and audit readiness

· Adherence to change control procedures and timelines

Failure to meet defined KPIs may result in corrective actions or service credits, as defined in the governing agreement.

5. Roles and Responsibilities

5.1 Contractor Responsibilities

The Contractor shall:

· Perform all services in accordance with this SOW

· Comply with all applicable site SOPs, Work Instructions, and quality procedures

· Maintain accurate, complete, and timely documentation

· Proactively communicate risks, issues, and constraints

· Support regulatory inspections and audits, as required

5.2 Client Responsibilities

Client shall:

· Provide necessary system access, onboarding, and training

· Define system ownership, priorities, and scope boundaries

· Provide oversight, governance, and escalation support

· Ensure availability of required site procedures and documentation

6. Key Personnel / Qualifications

The Contractor shall provide personnel with the following qualifications:

· Experience administering GxP-regulated computerized systems

· Working knowledge of:

o DCS/SCADA systems (e.g., DeltaV, Rockwell FactoryTalk, Metasys)

o Historian systems (e.g., PI)

o Laboratory and analytical systems (e.g., LabX, Sartocheck 5, Unicorn, ThinManager, Nova Biomass)

· Understanding of:

o Data integrity principles (ALCOA+)

o Change control and CAPA processes (TrackWise)

o Computerized System Validation (CSV)

7. Term and Level of Effort

· Duration: Six (6) months, with potential extension upon mutual agreement

· Level of Effort: Approximately forty (40) hours per week

· On-call Support: Minimal, as required to support critical operations.

8. Assumptions and Exclusions

· System engineering, design, or development activities are out of scope unless explicitly authorized.

· Project-based automation development requires separate approval and funding.

· Non-OT/Automation infrastructure support (e.g., enterprise servers, networks) remains the responsibility of IT unless otherwise specified.

TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.