What are the responsibilities and job description for the Lab Systems IT Administrator position at Alliance Biotech Solutions?
Alliance Biotech Solutions (ABS) is a quality partner providing first in class solutions to the biotech and life sciences industry. With Engineering, Qualification, and Compliance solutions, we are more than just consultants - we're strategic partners committed to excellence. At ABS, our greatest asset is our people. Our team members are the cornerstone of our service delivery, and we're dedicated to fostering an environment where talent thrives, and potential is unlimited.
Position Summary
The Lab Systems Administrator plays a critical role in managing the implementation, maintenance, and compliance of benchtop laboratory systems within a GMP biotech manufacturing facility. This position ensures that all laboratory systems meet regulatory requirements, including 21 CFR Parts 210, 211, 11, EU Annex 11, GLP, GMP, and ISO standards. The administrator will collaborate closely with laboratory personnel, IT teams, computer system validation experts, and QA professionals to ensure seamless integration, operation, and validation of lab systems while maintaining a compliant state.
This role requires a strong understanding of 21 CFR Part 11, current life science industry Data Integrity standards, Windows-based operating systems and networks, laboratory equipment, software, and IT infrastructure. Additionally, the Lab Systems Administrator must demonstrate a strong commitment to ensuring data integrity and regulatory compliance, supporting system lifecycle management in a highly regulated environment.
Position Responsibilities
- Evaluate lab system software and hardware through hands-on research, utilizing user manuals and vendor support to troubleshoot and optimize functionality.
- Lead and perform system configurations, implementing technical or procedural mitigations to ensure compliance with 21 CFR Part 11, Data Integrity standards, and regulatory requirements.
- Configure and manage Windows operating systems for lab systems software operations including data folder security, troubleshooting, and Windows event logs to maintain system integrity and security.
- Develop, maintain, and update system configuration documentation, system administration procedures, and user access control records.
- Conduct regular system maintenance, implement necessary updates, and proactively monitor system health, availability, and performance.
- Manage and enforce user access controls and permissions, ensuring compliance with site processes and Data Integrity requirements.
- Respond promptly to technical issues and service requests, providing timely resolutions to minimize disruptions to laboratory operations.
- Coordinate with vendors to oversee application and firmware updates, patches, and fixes, serving as a technical liaison between stakeholders.
- Notify the System Owner/Business Process Owner of scheduled operating system software upgrades, patches, and hotfix deployments to ensure proper planning and execution.
- Maintain comprehensive application support documentation, including system configurations, troubleshooting guides, and change management records.
Qualifications
- Strong communication and interpersonal skills to effectively collaborate with stakeholders across all levels, including laboratory personnel, IT teams, and quality assurance.
- Ability to work independently and as part of a cross-functional team in a fast-paced, regulated environment.
- Hands-on experience in a life science laboratory environment, preferably with knowledge of laboratory equipment, scientific software, and data acquisition systems.
- Experience in computer system validation (CSV), particularly for laboratory or manufacturing systems, ensuring compliance with GMP, GLP, and 21 CFR Part 11 requirements.
- Proactive problem-solving skills with the ability to investigate and troubleshoot system issues independently.
- Direct experience with multiple types of laboratory system software, including installation, configuration, and maintenance.
- An overall understanding of Windows operating systems, Windows folder security, user/group management, and network configurations.
- In-depth knowledge of data integrity standards, including ALCOA principles, 21 CFR Part 11, and Annex 11 compliance requirements.
- An understanding in IT infrastructure, including Windows-based networks, system administration, and security best practices.
Preferred Qualifications
- Bachelor’s degree in Computer Science, Information Technology, or a related field OR a bachelor’s degree in a scientific discipline with a strong technical background in laboratory systems.
- Programming or scripting experience, such as Windows Batch Scripts or Python.
- Experience with Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), and scientific software applications.
- Fundamental networking knowledge, including IP addressing, network configurations, and cybersecurity best practices.
- Familiarity with Quality Control (QC) and manufacturing processes in a regulated GMP environment.
Benefits
Industry competitive wage as a full-time employee
Flexible Paid Time Off
Bonus plans
Medical, Dental and Vision Insurance with low employee cost
Employer paid long term and short-term disability
401k plan with employer contributions
Alliance Biotech Solutions does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Alliance Biotech Solutions, and Alliance Biotech Solutions will not be obligated to pay a placement fee.
All persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
