Partner with the Process Translation and Analytical Laboratories functional areas and site, group, and global IT teams to implement and support digital laboratory solutions that enable the Foundry’s operational objectives
Key lab systems include: Laboratory Information Management Systems (LIMS), Laboratory Execution Systems (LES), Electronic Lab Notebooks (ELN), Chromatography Data Systems (CDS), and Environmental Monitoring (EM) platforms
Drive and support system design, configuration, validation, and release - serving as an IT subject matter expert (SME) for analytical laboratory IT systems at the Foundry
Lead system design and configuration sessions with analytical lab SMEs for LIMS, LES, ELN, and CDS platforms, translating business and scientific processes into validated technical solutions
Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in compliance with 21 CFR Part 11 and EU Annex 11
Manage data integrity requirements across lab systems and ensure audit readiness for regulatory inspections
Coordinate instrument integration and data flows between lab equipment and LIMS/LES platforms
Support site deployment and upgrade of analytical laboratory IT systems throughout the facility’s startup and operational phases
Produce and maintain Computer System Validation (CSV) documentation, standard operating procedures (SOPs), and validation plans in alignment with applicable regulatory frameworks
Ensure systems remain in a validated state and manage their lifecycle through releases, recapitalization, and retirement
Collaborate with site and global IT system teams to ensure operational readiness of laboratory systems supporting the Foundry’s go-live objectives
Support audits and provide oversight for management reviews, laboratory metrics, equipment records, and laboratory documentation.

Requirements

Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field
3+ years of relevant experience in information technology, engineering, computer system validation, quality control support, or a related area
Demonstrated experience with Computer System Validation (CSV) methodology
Strong working knowledge of analytical laboratory IT systems including: LIMS: LabVantage, LabWare, or equivalent; ELN: Benchling, Signals Notebook, or equivalent; CDS: Empower, or equivalent; LES/MES: L7, MODA, or equivalent
Solid knowledge of CSV process and electronic records/electronic signatures (ERES) requirements
Experience working in a GMP-regulated environment (pharmaceutical, biotech, or equivalent)
Demonstrated ability to prepare and execute IQ/OQ/PQ protocols and associated documentation
Experience with API/middleware integration and instrument connectivity between lab equipment and informatics platforms
Understanding of data integrity frameworks applicable to GMP lab environments
Familiarity with Agile or iterative delivery methodologies in a regulated setting
Demonstrated learning agility and curiosity; ability to analyze, anticipate, and resolve complex issues through sound problem-solving
Ability to accurately translate business and scientific processes into IT requirements and solutions
Effective communicator across diverse forums and audiences, including technical peers, QA, and business stakeholders
Certification in relevant IT areas (e.g., ITIL, cloud, AI) is a plus.

Benefits

Eligibility to participate in a company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Computer System Validation (CSV)Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)API integrationmiddleware integrationdata integrityanalytical laboratory IT systemsLIMSLES

Soft Skills

problem-solvinglearning agilitycommunicationcollaborationanalytical thinkingcuriosityability to translate processes into IT requirementsoversightleadershiporganizational skills

Certifications

ITILcloud certificationAI certification