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 lifecycle management of laboratory computing systems and related technologies that support GMP-regulated laboratory operations. The role provides technical ownership and support for laboratory computerized systems, infrastructure, instrumentation interfaces, applications, and associated services throughout their lifecycle. It combines laboratory computing expertise, engineering discipline, GMP knowledge, a quality mindset, and operational ownership, extending beyond traditional IT support to include understanding laboratory requirements, assessing risks, executing controlled activities, verifying outcomes, maintaining complete documentation, and keeping systems in a compliant and validated or qualified state as applicable. The position collaborates with Laboratory Operations, Quality Assurance, Engineering, Facilities, Cybersecurity, Infrastructure, Service Management, vendors, and other stakeholders to ensure laboratory computing services are reliable, secure, supportable, and compliant. The role provides technical leadership for system lifecycle work, change control, risk management, testing and verification, data integrity, incident and investigation support, documentation, mentoring, and continuous improvement. It also supports regulatory inspections and audits as a technical subject matter expert.

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 within 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 associated services.
Maintain reliable operation of laboratory applications, computerized systems, workstations, instruments, interfaces, and supporting infrastructure.
Serve as a technical subject matter expert for assigned laboratory computing platforms and services.
Lead troubleshooting of complex technical issues and coordinate resolution 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 GMP requirements, company policies, SOPs, work instructions, and quality processes, using a risk-based approach.
Assess how changes to computerized systems 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 in 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, interfaces, data flows, infrastructure, and upstream and downstream impacts.
Identify obsolete, unsupported, or high-risk technologies and develop remediation strategies; support lifecycle roadmaps and modernization initiatives.
Lead or provide technical ownership for 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 generate appropriate objective evidence.
Develop and execute technical testing and verification appropriate to system risk and intended use; review expected and actual results and investigate unexpected outcomes.
Support validation, qualification, or computerized assurance activities, working with CSV/CSA and Quality organizations on appropriate lifecycle controls.
Ensure test evidence is complete, accurate, traceable, and attributable, and support independent review of critical technical activities where required.
Apply data-integrity principles and controls for electronic records, user access, audit trails, configurations, interfaces, and data flows; escalate suspected data-integrity issues.
Ensure system access and configuration activities follow approved procedures and segregation-of-duty requirements.
Provide technical leadership for complex incidents affecting GMP laboratory systems and support deviation and nonconformance investigations.
Develop problem statements and event timelines, gather and preserve technical evidence, participate in root-cause analysis and impact assessments, and develop corrective and preventive actions where appropriate.
Verify remediation effectiveness and drive systemic improvements for recurring issues.
Create and maintain clear, accurate, complete, timely, and traceable technical documentation in accordance with Good Documentation Practices and data-integrity requirements.
Maintain system configuration records, technical procedures, support documentation, testing evidence, and change records so work can be reconstructed, including what was performed, by whom, when, and with what result.
Identify and correct documentation deficiencies through appropriate quality processes.
Mentor engineers and technical staff in laboratory computing, GMP, quality, troubleshooting, and controlled execution; review technical approaches and guide complex work.
Promote consistent engineering practices, build technical depth and redundancy, and support development of standards, procedures, troubleshooting guides, and knowledge-management practices.
Identify opportunities to improve laboratory system reliability, service quality, compliance, and operational efficiency.
Use incident, service, and system data to identify recurring problems and systemic weaknesses; drive automation and standardization where appropriate without compromising GMP controls.
Reduce unnecessary manual processes and operational dependencies, improve availability and supportability, and contribute to long-term technology roadmaps.
Consistently understand requirements, follow approved controls, identify risks, define verification before significant work, execute approved plans, verify results, document actual work, escalate unexpected conditions, and stop when proceeding is inappropriate.
Take ownership of technical and quality outcomes and coach others to apply the same standards.