GMP Lab Computing Services Engineer

Position Summary

The GMP Lab Computing Services (LCS) Engineer is a technical role responsible for the reliable, compliant, and lifecycle management of laboratory computing systems and associated technologies supporting GMP-regulated laboratory operations. This role provides technical support for laboratory computerized systems, infrastructure, instrumentation interfaces, applications, and associated services throughout their lifecycle. The position requires a strong combination of laboratory computing expertise, engineering discipline, GMP knowledge, quality mindset, and operational ownership.

Key Responsibilities

Laboratory Computing Services

• 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 multiple 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 laboratory system lifecycle activities including implementation, configuration, maintenance, upgrades, retirement, and decommissioning.
• Maintain appropriate technical documentation, system information, configuration records, and support procedures.

GMP and Quality

• Perform all activities in accordance with applicable GMP requirements, company policies, SOPs, work instructions, and quality processes.
• Apply a risk-based approach to laboratory computing activities.
• Understand how changes to computerized systems may affect laboratory operations, product quality, data integrity, and regulatory compliance.
• Ensure technical activities are appropriately planned, controlled, executed, verified, and documented.
• Recognize when a technical activity requires change control, validation/assurance, deviation management, Quality review, or additional approval.
• Promote a culture in which quality is embedded into technical execution rather than treated as a post-implementation activity.
• Demonstrate willingness to stop work and escalate when requirements, procedures, system state, or expected results are unclear or inconsistent.
• Support internal and external regulatory inspections and audits as a technical subject matter expert.

Computerized System Lifecycle

• Provide technical leadership throughout the lifecycle of GMP computerized systems.
• Participate in system planning, requirements definition, design, configuration, testing, implementation, maintenance, upgrades, and retirement.
• Ensure system configurations remain aligned with approved requirements and intended use.
• Maintain awareness of system dependencies, interfaces, data flows, infrastructure, and upstream/downstream impacts.
• Support lifecycle documentation and ensure technical records remain current.
• Identify obsolete, unsupported, or high-risk technologies and develop appropriate remediation strategies.
• Support system lifecycle roadmaps and technology modernization initiatives.

Change Control and Risk Management

• Lead or provide technical ownership for changes affecting laboratory computerized systems.
• Assess technical, operational, GMP, and data-integrity impacts of proposed changes.
• Develop appropriate implementation, testing, verification, and rollback strategies.
• Ensure changes are implemented according to approved plans.
• Confirm that completed changes achieve predefined acceptance criteria before considering work complete.
• Provide technical input to risk assessments and determine appropriate controls based on system and business risk.
• Ensure appropriate objective evidence is generated and retained.

Verification, Testing, and Validation/Assurance

• Develop and execute technical testing and verification activities appropriate to the risk and intended use of the system.
• Ensure acceptance criteria are established before execution.
• Review expected versus actual results and investigated unexpected outcomes.
• Provide technical support for validation, qualification, or computerized assurance activities as applicable.
• Ensure test evidence is complete, accurate, traceable, and attributable.
• Support independent review of critical technical activities where required.
• Partner with CSV/CSA and Quality organizations to ensure appropriate lifecycle controls are applied.
• Recognize that successful technical execution does not constitute completion until required verification and documentation are complete.

Data Integrity

• Apply data-integrity principles to laboratory computerized systems and associated services.
• Understand controls associated with electronic records, user access, audit trails, system configurations, interfaces, and data flows.
• Ensure technical activities do not compromise the integrity, availability, or traceability of regulated data.
• Support assessment and remediation of data-integrity risks.
• Escalate suspected data-integrity issues promptly and appropriately.
• Ensure system access and configuration activities are performed according to approved procedures and segregation-of-duty requirements.

Incident, Deviation, and Investigation Support

• Provide technical leadership for complex incidents affecting GMP laboratory systems.
• Support deviation and nonconformance investigations.
• Develop technically sound problem statements and event timelines.
• Gather and preserve appropriate technical evidence.
• Participate in root-cause analysis and impact assessments.
• Develop corrective and preventive actions where appropriate.
• Ensure technical remediation is verified for effectiveness.
• Identify recurring issues and drive systemic improvements rather than repeated temporary fixes.

Documentation and Good Documentation Practices

• Create and maintain clear, accurate, complete, timely, and traceable technical documentation.
• Follow applicable Good Documentation Practices and data-integrity requirements.
• Ensure documentation accurately reflects work actually performed.
• Maintain system configuration records, technical procedures, support documentation, testing evidence, and change records.
• Ensure technical records allow reconstruction of what was performed, by whom, when, and with what result.
• Identify and correct documentation deficiencies through appropriate quality processes.

Technical Support and Mentoring

• Serve as a technical leader and subject matter expert within the LCS organization.
• Mentor engineers and technical staff in laboratory computing, GMP, quality, troubleshooting, and controlled execution.
• Establish and promote consistent engineering practices across the team.
• Coach engineers to think beyond task completion and focus on verification, documentation, and risk.
• Review technical approaches and provide guidance on complex issues.
• Build technical depth and redundancy within the LCS organization.
• Support development of engineering standards, procedures, troubleshooting guides, and knowledge-management practices.
• Help establish a culture of accountability, ownership, and continuous improvement.

Continuous Improvement

• 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.
• Develop strategies to improve system availability, supportability, and lifecycle sustainability.
• Contribute to long-term laboratory computing technology roadmaps.