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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. The LCS Engineer is expected to operate beyond traditional IT support. The role requires the engineer to understand the business and laboratory requirements, assess risk, execute controlled technical activities, verify outcomes, maintain complete documentation, and ensure systems remain in a compliant and validated/qualified state as applicable.
The position works closely 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.
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.
Required Qualifications
- Bachelor’s degree in computer science, Computer Engineering, Electrical Engineering, Information Technology, Life Sciences, or 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.
- Demonstrated ability to work independently and exercise sound technical judgment.
- Ability to balance operational urgency with GMP and quality requirements.
Preferred Qualifications
- 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.
Core Competencies
Technical Excellence
Demonstrates advanced knowledge of laboratory computing technologies and can independently troubleshoot complex systems and infrastructure.
GMP and Quality Mindset
Understands that quality is part of technical execution and consistently incorporates GMP, data integrity, risk management, verification, and documentation into daily work.
Ownership and Accountability
Takes end-to-end ownership of technical problems and ensures that issues are resolved, verified, documented, and appropriately closed.
Risk-Based Decision Making
Considers technical, operational, compliance, data-integrity, and business risks before making decisions or implementing changes.
Communication
Clearly communicates technical issues, risks, decisions, and recommendations to both technical and non-technical stakeholders.
Collaboration
Builds effective relationships across LCS, Laboratory Operations, Quality, CSV/CSA, Engineering, IT, Cybersecurity, and other organizations.
Continuous Improvement
Identifies opportunities to improve reliability, efficiency, standardization, compliance, and user experience.
Expected Behaviors
The GMP LCS Engineer is expected to consistently demonstrate the following behaviors:
- Understand the requirement before performing the task.
- Follow approved procedures and controls.
- Identify potential GMP, data-integrity, and operational risks before execution.
- Define how success will be verified before performing significant technical work.
- Execute according to the approved plan.
- Verify the result against predefined acceptance criteria.
- Document what actually occurred.
- Escalate unexpected conditions promptly.
- Stop when it is not appropriate to proceed.
- Never bypass GMP controls simply to meet a deadline.
- Take ownership of technical and quality outcomes.
- Coach others to apply the same standards Orion is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, citizenship status, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
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