IT Lab Computing Support Specialist

Orion Innovation•Olympia, WA

About The Position

The GMP Lab Computing Services (LCS) Engineer is responsible for the reliable, compliant operation and lifecycle management of laboratory computing systems and related technologies supporting GMP-regulated laboratory operations. The role provides technical support for laboratory computerized systems, infrastructure, instrumentation interfaces, applications, and associated services throughout their lifecycle. It combines laboratory computing expertise, engineering discipline, GMP knowledge, quality-focused execution, and operational ownership, extending beyond traditional IT support. The engineer works with Laboratory Operations, Quality Assurance, Engineering, Facilities, Cybersecurity, Infrastructure, Service Management, vendors, and other stakeholders. The role requires understanding laboratory and business requirements, assessing risk, executing controlled technical activities, verifying outcomes, maintaining complete documentation, and keeping systems in a compliant and validated or qualified state as applicable. The engineer also provides technical leadership, mentors colleagues, supports inspections and investigations, and advances reliability, standardization, and continuous improvement.

Requirements

Bachelor’s degree in computer science, computer engineering, electrical engineering, information technology, life sciences, or a related technical discipline; equivalent relevant experience may be considered.
Significant experience supporting laboratory computing, computerized laboratory systems, scientific systems, instrumentation, or related technologies.
Demonstrated experience working in a GMP-regulated environment.
Strong understanding of GMP principles and Good Documentation Practices.
Demonstrated experience with controlled technical execution, change management, testing, and verification.
Strong troubleshooting and analytical problem-solving skills.
Experience supporting regulated computerized systems throughout their lifecycle.
Experience working with cross-functional teams, including Quality, Laboratory Operations, Engineering, Cybersecurity, Infrastructure, and vendors.
Strong technical writing and communication skills.
Ability to work independently and exercise sound technical judgment.
Ability to balance operational urgency with GMP and quality requirements.

Nice To Haves

Experience supporting pharmaceutical, biotechnology, medical-device, or other highly regulated laboratory environments.
Experience with computerized system validation (CSV) or computer software assurance (CSA).
Experience with laboratory informatics and laboratory applications.
Experience supporting laboratory instruments and instrument-to-system interfaces.
Experience with Windows infrastructure supporting laboratory systems.
Experience with virtualization, networking, databases, system interfaces, or enterprise infrastructure.
Experience with data-integrity assessments.
Experience with change control, deviation investigations, CAPA, and risk assessments.
Experience supporting regulatory inspections or audits.
Experience leading technical projects or system implementations.
Experience mentoring engineers or technical staff.

Responsibilities

Provide senior-level technical support and ownership for GMP laboratory computing systems and related services.
Maintain reliable operation of laboratory applications, computerized systems, workstations, instruments, interfaces, and supporting infrastructure.
Serve as a technical subject matter expert and lead troubleshooting of complex issues across technical and business teams.
Provide technical direction during system incidents, service interruptions, and complex operational events.
Develop sustainable solutions to recurring technical problems and reduce operational risk.
Support system lifecycle activities, including implementation, configuration, maintenance, upgrades, retirement, and decommissioning.
Maintain technical documentation, system information, configuration records, and support procedures.
Perform work in accordance with applicable GMP requirements, company policies, SOPs, work instructions, and quality processes.
Apply risk-based judgment and assess how technical changes may affect laboratory operations, product quality, data integrity, and regulatory compliance.
Plan, control, execute, verify, and document technical activities; identify when change control, validation or assurance, deviation management, Quality review, or additional approval is required.
Support internal and external regulatory inspections and audits as a technical subject matter expert.
Participate throughout computerized-system planning, requirements definition, design, configuration, testing, implementation, maintenance, upgrades, and retirement.
Keep system configurations aligned with approved requirements and intended use, maintain awareness of dependencies and data flows, and support current lifecycle documentation.
Identify obsolete, unsupported, or high-risk technologies and develop remediation strategies, lifecycle roadmaps, and modernization initiatives.
Lead or own changes affecting laboratory computerized systems; assess impacts and develop implementation, testing, verification, and rollback strategies.
Ensure changes follow approved plans, meet predefined acceptance criteria, and have appropriate objective evidence retained.
Develop and execute risk-appropriate technical testing and verification; review results and investigate unexpected outcomes.
Support validation, qualification, or computerized assurance activities and partner with CSV/CSA and Quality organizations on lifecycle controls.
Apply data-integrity principles to electronic records, user access, audit trails, system configurations, interfaces, and data flows; promptly escalate suspected data-integrity issues.
Provide technical leadership for complex incidents, support deviation and nonconformance investigations, gather technical evidence, participate in root-cause and impact assessments, and develop or verify corrective and preventive actions where appropriate.
Create and maintain accurate, complete, timely, traceable technical documentation that reflects work performed and allows reconstruction of what occurred, by whom, when, and with what result.
Mentor engineers and technical staff, review technical approaches, promote consistent engineering practices, and develop team capability and knowledge-management practices.
Identify and drive improvements to reliability, service quality, compliance, operational efficiency, automation, standardization, availability, and lifecycle sustainability.