Nature and Scope of Job

Provide hands-on support for laboratory instrument software and instrument PCs in a regulated environment. Focus on Windows-based acquisition/analysis apps, user support, data integrity, and high-quality documentation (manuals, config specs, Part 11/Annex 11 and risk assessments, admin SOPs). Ensure fast, reliable support while maintaining validated state and compliance.

Primary Responsibilities

Instrument application support

• Administer and support instrument control, acquisition, and analysis software (e.g., plate readers, imaging, flow cytometry, spectroscopy).
• Manage method/template libraries, user roles/permissions, e-signature workflows (where applicable), and instrument queues.
• Coordinate firmware/driver updates and software patches under change control.

Windows and instrument PC management

• Maintain instrument workstations (often isolated or on constrained networks): OS hardening, time sync, antivirus exclusions, local admin policies, and GPO exceptions.
• Manage storage paths, raw data folders, and secure network shares; monitor performance, logs, and disk capacity.
• Execute backup/restore procedures and periodic restore testing.

User support and service quality

• Primary contact for scientists and QA for instrument app issues, errors, and how-to questions.
• Triage tickets, perform root-cause analysis, escalate to vendors when needed; meet response/resolution SLAs.
• Provide training, quick-reference guides, and job aids tailored to each instrument software.

Data integrity and compliance (ALCOA+, 21 CFR Part 11/Annex 11)

• Ensure audit trails, access controls, electronic signatures (if used), time-stamps, and record protection are configured and verified.
• Conduct and maintain Part 11 assessments, risk assessments, and periodic reviews for each instrument application.
• Protect raw data from modification/deletion; manage retention/archival and read-only controls.

Documentation and change control

• Create/maintain admin SOPs, configuration specifications, system manuals, method/template management procedures, and data flow diagrams.
• Maintain configuration baselines for each instrument PC/application; track versions, patches, and exceptions.
• Support CSV/CSA where applicable (intended use, impact/risk), manage changes via CC, capture deviations and CAPAs.

Integrations and data flows

• Support connections to SDMS/file repositories, printers/labels, barcodes, and (when applicable) outbound transfers to ELN/LIMS via controlled interfaces.
• Validate and document data mappings, error handling, and recovery steps for transfers.

Vendor and lifecycle coordination

• Work with OEMs (e.g., Thermo, Revvity, Molecular Devices) on defects, patches, and upgrades; track SLAs and release notes.
• Schedule and support IQ/OQ/PQ activities with vendors/QA; plan preventive maintenance windows with minimal downtime.

Additional Responsibilities

• Performs other related duties and assignments as required

Qualifications

• 2 years administering lab instrument applications in GxP settings
• Strong Windows administration basics in networking, permissions, and troubleshooting logs/services.
• Hands-on with 21 CFR Part 11/Annex 11, ALCOA+, audit trails, e signatures, access control, and backup/archival.
• Proven documentation skills (SOPs, configuration specs, Part 11/risk assessments, change/validation evidence).
• Service-oriented communicator; comfortable with on-call rotations and coordinating across QA/IT/Vendors.
• Nice to have:
• PowerShell for admin tasks
• Experience with SDMS, checksum/verification tools, and ITSM/ticketing (ServiceNow/Jira).
• Familiarity with time-sync/NTP, USB device control, and endpoint protection policies specific to instrument PCs.

Education & Certifications

• Bachelor's degree in Computer Science or Information Systems or related field.
• Master's Degree preferred

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Compensation

Salary/Hourly Rate Range (W2): USD 06.00 - 70.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM's compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate's qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.com/careers