IT Lab Systems Specialist

Job Description

Job Description

Position: IT Lab Systems SpecialistSalary Range: $75,000 - $95,000Location: Exton, PA (On-site)About PharmaronPharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit You'll DoReporting to the Director of IT, the IT Lab Specialist plays a critical role in supporting and advancing IT operations within a GxP-regulated laboratory environment. This position ensures that laboratory computer systems, connected instruments, and supporting infrastructure operate securely, reliably, and in full compliance with regulatory, quality, and data integrity standards. Working cross-functionally with Scientific Operations, Quality, and IT teams, the IT Lab Specialist supports system implementation, validation, lifecycle management, backup and recovery processes, and continuous improvement initiatives across laboratory technologies.Key ResponsibilitiesProvide hands-on IT support for laboratory instruments, applications, and computerized systems within a GxP-regulated environment Troubleshoot and resolve hardware, software, and network connectivity issues related to laboratory systems and instruments (e.g., Cell Counters, Flow Cytometers, LIMS, PCR systems)Partner with instrument and software vendors to coordinate maintenance, technical support, upgrades, and escalationsManage system backups, data integrity verification, and restore testing in accordance with internal policies and regulatory requirementsCreate and maintain technical system documentation for laboratory instruments, including hardware/software configurations, architecture, interfaces, and data flow mappingsAuthor and maintain SOPs and technical documentation supporting laboratory IT operations, backup processes, and system administration activitiesAdminister user accounts, access controls, and security permissions in alignment with established procedures and segregation of duties requirementsServe as the document owner for IT-related GxP procedures, including system administration, backup/restoration, and user management processesSupport qualification and validation activities (IQ/OQ/PQ and CSV) for laboratory systems in collaboration with QA and external vendorsEnsure compliance with 21 CFR Part 11, EU Annex 11, GDPR, EO 14117, and internal IT and quality standardsLead and support change control activities, including impact assessments, risk evaluations, testing coordination, and approval documentation for system updates and configuration changesPerform periodic reviews of computerized systems, including patch management, audit trail reviews, and lifecycle assessmentsSupport laboratory system upgrades, integrations, and migrations involving enterprise platforms such as LIMS and ELNParticipate in internal and external audits as the subject matter expert (SME) for laboratory IT systems and infrastructureTrain and support laboratory personnel on IT procedures, system usage, data handling, and cybersecurity best practicesCollaborate with cross-functional IT teams to ensure operational continuity and timely resolution of technical issues across laboratory and business systemsOccasional travel to U.S. laboratory and CGT sites may be requiredWhat We're Looking ForBachelor's degree in Information Technology, Computer Science, or a related discipline 5–7 years of IT experience within GMP, GLP, or other regulated pharmaceutical or biotechnology environmentsStrong knowledge of laboratory instruments and computerized systems, including LIMS, LCMS, HPLC, Flow Cytometry, and PCR platformsDeep understanding of GxP compliance, data integrity principles, and regulated documentation practicesHands-on experience with Windows-based environments, backup and recovery technologies, and basic network infrastructureExperience administering databases such as Oracle and SQL ServerKnowledge of cybersecurity principles and controls within regulated environmentsFamiliarity with computer system validation (CSV), SDLC methodologies, and risk-based system assessmentsStrong analytical, organizational, and communication skills with the ability to work effectively across technical and scientific teamsWhy Pharmaron?Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:Comprehensive Medical, Dental & Vision Insurance with significant employer contributions401(k) Retirement Plan with generous employer matchingGenerous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balanceEmployer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability InsuranceEmployee Assistance Program (EAP), mental health resources, and wellness programsFamily-friendly benefits, including fertility support and maternity resourcesProfessional development and career growth opportunities within a leading global CRO/CDMOHow to Apply:Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences. #LI-KS1