## [IT/OT Senior Lab Specialist](/req-10086628-itot-senior-lab-specialist "IT/OT Senior Lab Specialist") Job ID REQ-10086628 Sep 09, 2026 LOC_US ### About the Role Key Responsibilities: - Lead design, configuration, installation, and maintenance of lab instrumentation/equipment software and associated hardware; including interacting with other teams as necessary, e.g., process engineering. - Ensure lab instruments/equipment maintain high availability for lab owners. Work closely with vendors to ensure appropriate instrument/equipment architectures and connectivity are designed and implemented. - Manage work order execution to ensure on-time completion of all required maintenance related activities on lab equipment (e.g, user reviews, audit trail reviews). - Participate as an SME in health authority and internal inspections ensuring full compliance with applicable procedures. - Track and drive to on-time completion of corrective and preventive actions (CAPA), including escalation of issues related to closure of CAPA, as appropriate. Lead lab instrument change controls per applicable procedures. - Prepare, review, approve, archive GxP and non-GxP instrument/equipment documentation, e.g., User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS). - Lead discussions with internal business partners on priorities, timelines and transparent sharing of information. - Support operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant lab environment. Problem solve technical related issues impacting lab operations. - Create and update procedures to drive operational efficiency and compliance. Implement and revise SOPs to conform with standards and policies. Support investigations of non-conformances related computerized systems. - Participate as active IT/OT team member providing support to other functions as necessary. Support 24x7 site-based operations including rotating on-call responsibilities. Essential Requirement: - B.S. degree in Engineering, Computer Science, IT or related technical field. - 8 years' work experience in pharmaceutical or biopharmaceutical-based lab operations, or equivalent work experience (12 years) in pharmaceutical or biopharmaceutical-based lab operations. - Excellent oral and written communication skills. - Experience leading teams installing, configuring and maintaining lab systems in a GMP environment. - Experience implementing computerized system in a corporate network environment. - Knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems. - Knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high quality processes and end products. - Experience working with and leading 3rd parties (both in-sourcing and outsourcing). Desirable Requirement: - Ability to support contingency plans and logically work through complex issues in a pressure filled atmosphere. - Provide technical support on computerized system lab instrument issues when driving towards issue resolution. Up to 10% travel may be required. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $108,500 and $201,500.00 annually. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. \#LI-Onsite EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. ### Role Requirements **Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? [https://www.novartis.com/about/strategy/people-and-culture](https://www.novartis.com/about/strategy/people-and-culture "https://www.novartis.com/about/strategy/people-and-culture") **Benefits and Rewards:** Learn about all the ways we’ll help you thrive personally and professionally. [Read our handbook (PDF 30 MB)](https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf) Division DIV_TO Business Unit Information Technology Location LOC_US Site Durham Company / Legal Entity U061 (FCRS = US061) Novartis Services, Inc. Functional Area FCT_TO Job Type Full time Employment Type Regular Shift Work No [Apply to Job](https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Durham/IT-OT-Senior-Lab-Specialist_REQ-10086628-1 "Apply to Job") ![careers default image](https://prod1.jobapi.novartis.com.cn/themes/custom/cosmos/patterns/images/careers-default-image.webp "careers default image") Job ID REQ-10086628 ### IT/OT Senior Lab Specialist [Apply to Job](https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Durham/IT-OT-Senior-Lab-Specialist_REQ-10086628-1 "Apply to Job")