Senior Information Technology GxP Technical Analyst

POSITION SUMMARY:

This position leads the design, development, and delivery of the Information Technology (IT) solutions and applications that run the company’s Bioanalytical Laboratory. The position translates laboratory and scientific workflow requirements into configured, integrated, and validated computerized systems - LIMS, instrument data systems, electronic records, and quality systems - and ensures GLP/GCLP and 21 CFR Part 11 standards are met.

The Senior IT GxP Technical Analyst partners closely with Bioanalytical Lab scientists and operations leadership, Quality Assurance, Cybersecurity, Enterprise Systems, software vendors, and the Senior IT GxP and Quality Compliance Analyst, who provides independent compliance oversight of delivered solutions. As the senior technical authority for lab systems, the role sets technical direction and standards, owns the most complex solutions end to end, and mentors other IT staff in validated delivery practices.

DUTIES AND RESPONSIBILITIES:

• Act as senior technical authority for Bioanalytical Laboratory systems, setting design, configuration, and integration standards and owning the technical roadmap for the lab application landscape.
• Gather, analyze, and document business, laboratory, and data requirements from the Bioanalytical Lab, and translate them into user requirement specifications, functional designs, and configuration specifications.
• Design, configure, develop, and deploy GxP solutions supporting sample management, testing workflow management (LIMS), instrument integration, electronic records, and quality system management.
• Execute the technical side of the system lifecycle - environment build and configuration management, code and configuration version control, unit and integration testing, and authoring and executing IQ/OQ/PQ test scripts.
• Produce technical validation documentation - design specifications, configuration records, traceability, and test evidence - to the standard required by IT Compliance and Quality Assurance for approval.
• Manage technical change controls and releases, ensuring changes are risk-assessed, tested, documented, and promoted only through approved, validated pathways.
• Lead delivery of complex or multi-system initiatives end to end, including effort estimation, technical planning, coordination of internal resources and software vendors, and technical decision-making.
• Provide application-level support and troubleshooting for GxP systems, performing root cause analysis, resolving defects, and escalating incidents with data integrity impact to IT Compliance and Quality Assurance.
• Support vendor-delivered upgrades, patches, and platform releases, including impact assessment, regression testing, and coordination with software suppliers.
• Partner with IT Compliance, Quality Assurance, and lab scientists to ensure delivered solutions are fit for purpose, inspection-ready, and maintained in a validated state.

EXPERIENCE AND QUALIFICATIONS:

• Bachelor’s degree in Information Technology, Computer Science, Information Systems, Bioinformatics, or related discipline; equivalent combination of education and experience considered.
• Minimum 6 years of experience designing, configuring, or developing computerized systems, including at least 3 years in a GLP and/or GCLP regulated environment.
• Hands-on experience implementing, configuring, or administering a LIMS (e.g., LabWare, LabVantage, STARLIMS, Watson LIMS) and integrating laboratory instruments or chromatography data systems.
• Experience delivering solutions through a validated SDLC, including authoring specifications and executing IQ/OQ/PQ test scripts.
• Demonstrated experience leading technical delivery of computerized system implementations or major upgrades, including vendor and stakeholder coordination.
• Experience working in an IT role in a high throughput clinical research organization (CRO) strongly preferred.
• Experience with bioanalytical workflows - sample lifecycle, assay runs, chain of custody, and study data reporting - strongly preferred.
• Experience mentoring or providing technical review for other IT staff strongly preferred.

KNOWLEDGE, SKILLS AND ABILITIES:

• Advanced knowledge of GxP compliance requirements for computerized systems, including 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data integrity principles.
• Practical technical skills in configuration, scripting, and data work, including SQL, reporting tools, APIs and web services, and at least one scripting or programming language.
• Strong understanding of system architecture, environments, interfaces, databases, and access and security models for validated applications.
• Ability to translate scientific and laboratory workflows into technical designs and configured system behavior.
• Disciplined documentation habits; able to produce inspection-ready technical evidence as a normal part of delivery.
• Strong analytical and troubleshooting skills, including root cause analysis of application and interface issues.
• Strong technical judgment: knows when to configure, when to customize, when to adopt vendor functionality, and when to standardize, balancing validation burden against business need.
• Ability to make sound technical design decisions autonomously and justify them to compliance, Quality Assurance, and business stakeholders.
• Ability to provide day to day guidance/mentoring to others in a consistently supportive and collaborative approach.
• Strong written and verbal communication skills, including the ability to explain technical concepts and trade-offs to scientists, Quality Assurance, and non-technical stakeholders.

COMPENSATION SUMMARY

The annual base salary for this position ranges from $116,600 to $177,800. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate’s knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.

BENEFITS SUMMARY

At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

EEO/AA STATEMENT

MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please visit here. Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.