Instrument Systems Administrator — GMP/GxP Validation

Eurofins BioPharma Product Testing North America; Lancaster (Lancaster County); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Life and disability insurance

401(k) with company match

Paid holidays and vacation

Dental and vision options

Job summary

Eurofins USA BioPharma Services seeks a Subject Matter Expert (SME) to maintain validated instrumentation and support qualification activities in a GMP/GLP environment. You will assess, troubleshoot, repair, and implement CAPAs while ensuring electronic records compliance and routine system validation testing.

You will also review testing docs, coordinate testing efforts, and stay current with regulatory requirements.

Qualifications

• Bachelor's in physical science (chemistry, engineering, computer science, etc.). Additional years of directly‑related experience may be considered in lieu of degree (two years of directly related industry experience is equivalent to one full‑time year of college in related major)
• Authorization to work in the United States indefinitely without restriction or sponsorship

Responsibilities

• Maintain instrument/software in a validated state at all times. Perform assessment, trouble‑shooting, repair. Develop and implement CAPA to resolve issues as needed. Ensure completion of preventative maintenance and routine qualification testing.
• Install, configure software for electronic record compliance. Perform testing to identify gaps and develop remediation as required.
• Routinely analyze system logs/audit trails, perform software/firmware upgrades, update user account information, and complete periodic system compliance reviews.
• Coordinate installation and/or execute testing (as required).
• Review testing documentation generated by vendors and/or other team members. Compile and maintain documentation in an organized GXP compliant manner to demonstrate status.
• Applies GMP/GLP in all areas of responsibility, as appropriate
• Compliance - Ensure projects are completed in compliance with existing quality systems. Stay current with client, regulatory, validation, IT, and e‑record regulations and requirements. Assist with implementing new internal practices and procedures.
• Research - Research and on‑board new instrumentation; Assist with integration of instrumentation into existing data center environments and workflows
• Technical Writing - Provide technical input for validation deliverables, investigations, and develop/enhance procedures in accordance with established quality programs
• Training - Provide training to system users and other admins; Assist with developing training program and procedures
• Conducts all activities in a safe and efficient manner
• Performs other duties as assigned

Skills

Computer skills

Scientific skills

Organizational skills

Communication skills

Attention to detail

Independent work

Teamwork

Documentation skills

MS Word

MS Excel

Education

Bachelor's degree in physical science

Job description

Eurofins USA BioPharma Services seeks a Subject Matter Expert (SME) to maintain validated instrumentation and support qualification activities in a GMP/GLP environment. You will assess, troubleshoot, repair, and implement CAPAs while ensuring electronic records compliance and routine system validation testing.

You will also review testing docs, coordinate testing efforts, and stay current with regulatory requirements.