System Administrator

Position: System Administrator

Location: Lexington, MA (Hybrid remote)

Duration: 6 months (High possibility of extension)

Application System Administrator (Contractor)

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

Perform routine system administration activities for OT/Automation-supported applications and infrastructure, including but not limited to: DeltaV, Rockwell FactoryTalk, Metasys, PI Historian, LabX, Sartocheck 5 Filter Integrity Tester, Unicorn, ThinManager, and Nova Biomass systems

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:

User account reviews

Audit trail reviews

Antivirus and system logs

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 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:

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

Historian systems (e.g., PI)

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

Understanding of:

Data integrity principles (ALCOA )

Change control and CAPA processes (TrackWise)

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.