IT/OT Senior Lab Specialist

Novartis • Durham, NC

23h • Onsite

About The Position

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.

Requirements

• 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).

Nice To Haves

• 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.

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.

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• a generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Senior