IT/OT Senior Lab Specialist

Novartis; Durham (CA); On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis seeks an IT/OT Senior Lab Specialist to lead design, configuration, and maintenance of computerized laboratory systems in GMP and non-GMP settings. You will drive reliability, compliance, and continuous improvement across a highly regulated manufacturing and development environment.

The role requires extensive experience with lab instrumentation software, regulatory knowledge, CAPA and change control, and collaboration with cross-functional teams to optimize lab performance and ensure

Qualifications

• B.S. degree in Engineering, Computer Science, IT or related technical field.
• 8+ years’ work experience in pharmaceutical or biopharmaceutical-based lab operations (12 years in equivalent role).
• Excellent oral and written communication skills.
• Experience leading teams installing, configuring and maintaining lab systems in a GMP environment.
• Experience implementing computerized systems 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.
• Experience working with and leading 3rd parties (in-sourcing and outsourcing).

Responsibilities

• Lead design, configuration, installation, and maintenance of lab software/hardware across GMP/non-GMP environments.
• Ensure high availability of lab instruments; coordinate with vendors for architecture and connectivity.
• Manage work orders for maintenance and audit-related activities.
• Act as SME during health authority and internal inspections for compliance.
• Track CAPA closures and lead instrument change controls.
• Prepare and archive GxP/non-GxP documents (URS, FS, DDS/HDS/SDS).
• Engage with internal partners on priorities and timelines.
• Support operational excellence and quality initiatives; update SOPs and procedures.
• Provide IT/OT team support and 24x7 site coverage as needed.

Skills

Lab systems

GMP compliance

FDA 21 CFR 11

Quality by Design

Vendor management

CAPA management

Cross-functional leadership

Change control

Education

Bachelor’s degree in Engineering/CS/IT

Job description

Band

Level 4

Job Description Summary

Join Novartis and play a critical role in enabling cutting-edge laboratory operations that help bring innovative medicines to patients. As an IT/OT Senior Lab Specialist, you will lead the strategy, implementation, and lifecycle management of computerized laboratory systems across GMP and non-GMP environments, ensuring reliability, compliance, and operational excellence. This is an opportunity to work at the intersection of technology, quality, and science, partnering with cross-functional teams to optimize lab performance, drive continuous improvement, and support a highly regulated manufacturing and development environment where your expertise will directly impact business success and patient outcomes.

Job Description

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.

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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 [e-mail] call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

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 [e-mail] or call [phone] 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, 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.

Salary Range

$108,500.00 - $201,500.00

Skills Desired

Business Continuity, Cost Management, Decision Making, Operational Excellence, Problem Solving, Project Management, Quality Compliance, Risk Management, Stakeholder Management, Vendor Management