Novartis Farmacéutica
Laboratory Operational Technology and Applications Engineer
Novartis Farmacéutica, East Hanover, New Jersey, us, 07936
Laboratory Operational Technology and Applications Engineer
Job ID: REQ-10015312Date: Oct 22, 2024Location: USASummary
OnsiteAbout the role: The Senior Expert Laboratory IT/OT Systems and Applications Engineer provides the technical expertise and operational support for laboratory equipment automation and digital data, networking technology, and laboratory system applications at our Cell & Gene Therapy Technical Research and Development Clinical Facility. This role will be responsible for driving automation and IT solutions to integrate new clinical development equipment and systems, as well as new quality control systems into the Operational Technology infrastructure by working with system owners, equipment manufacturers, and Novartis IT. This role will work in liaison with the Development and Analytical Operations teams to meet the requirements and timelines to support new Cell & Gene Therapy projects, programs and Lean Digital Core initiatives.Your Key Responsibilities:
Lead the design, configuration, installation, and maintenance of automation software (Supervisory Control and Data Acquisition) and associated hardware, including interacting with other teams as necessary.Provide oversight or participation on all automation aspects of projects including integration of SAP, CMX, GDLIMS systems to include data concentration, batch reporting, and data retention.Maintain, troubleshoot, and ensure compliance of the GMP and non-GMP control systems utilized for processing equipment, analytical instrumentation, and system database infrastructure.Prepare scope of work and manage automation and OT Network contractors as required, completing work within project timelines.Act as liaison between the local East Hanover CGT organization and local & global IT organizations.Participate in discussions with internal business partners on priorities, timelines, and transparent sharing of information.Establish equipment specifications and standard documentation – User Requirements (URS), Functional Specification (FS), and Detail Design Specifications (DDS/HDS/SDS).Maintain procedures to meet GMP & DPQ requirements, FDA Code of Federal Regulations (CFR’s), internal company policies, and support site-based operations outside business hours as needed.Identify root causes, evaluate, and recommend optimal solutions to prevent future issues.Role Requirements:
B.S. degree in Engineering, Computer Science, or equivalent related technical experience.5+ years of cGMP Pharmaceutical IT system and applications experience or equivalent industry experience required.Good working knowledge of cGMPs and understanding of the concepts of GMP, GLP, FDA and Health Authority Guidelines, applicable regulations and standards (ANSI, ISO, GAMP, ATMP) including 21 CFR Part 11.Project management experience; may include leading teams or projects with demonstrated leadership skills.Excellent communication and team building skills when interacting with personnel and stakeholders.Interpersonal and operational savvy, managing people challenges and stakeholder engagement.Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you.Commitment to Diversity & Inclusion:
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment.Compensation and Benefits Summary:
The pay range for this position at commencement of employment is expected to be between $107,200-$160,800/year. The total compensation package may also include other elements, including a sign-on bonus, restricted stock units, and various paid time off benefits.Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected.Accessibility & Reasonable Accommodations:
The Novartis Group of Companies are committed to providing reasonable accommodation to individuals with disabilities.Division: DevelopmentBusiness Unit: Innovative MedicinesLocation: USASite: East HanoverCompany / Legal Entity: Novartis Pharmaceuticals Corporation
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Job ID: REQ-10015312Date: Oct 22, 2024Location: USASummary
OnsiteAbout the role: The Senior Expert Laboratory IT/OT Systems and Applications Engineer provides the technical expertise and operational support for laboratory equipment automation and digital data, networking technology, and laboratory system applications at our Cell & Gene Therapy Technical Research and Development Clinical Facility. This role will be responsible for driving automation and IT solutions to integrate new clinical development equipment and systems, as well as new quality control systems into the Operational Technology infrastructure by working with system owners, equipment manufacturers, and Novartis IT. This role will work in liaison with the Development and Analytical Operations teams to meet the requirements and timelines to support new Cell & Gene Therapy projects, programs and Lean Digital Core initiatives.Your Key Responsibilities:
Lead the design, configuration, installation, and maintenance of automation software (Supervisory Control and Data Acquisition) and associated hardware, including interacting with other teams as necessary.Provide oversight or participation on all automation aspects of projects including integration of SAP, CMX, GDLIMS systems to include data concentration, batch reporting, and data retention.Maintain, troubleshoot, and ensure compliance of the GMP and non-GMP control systems utilized for processing equipment, analytical instrumentation, and system database infrastructure.Prepare scope of work and manage automation and OT Network contractors as required, completing work within project timelines.Act as liaison between the local East Hanover CGT organization and local & global IT organizations.Participate in discussions with internal business partners on priorities, timelines, and transparent sharing of information.Establish equipment specifications and standard documentation – User Requirements (URS), Functional Specification (FS), and Detail Design Specifications (DDS/HDS/SDS).Maintain procedures to meet GMP & DPQ requirements, FDA Code of Federal Regulations (CFR’s), internal company policies, and support site-based operations outside business hours as needed.Identify root causes, evaluate, and recommend optimal solutions to prevent future issues.Role Requirements:
B.S. degree in Engineering, Computer Science, or equivalent related technical experience.5+ years of cGMP Pharmaceutical IT system and applications experience or equivalent industry experience required.Good working knowledge of cGMPs and understanding of the concepts of GMP, GLP, FDA and Health Authority Guidelines, applicable regulations and standards (ANSI, ISO, GAMP, ATMP) including 21 CFR Part 11.Project management experience; may include leading teams or projects with demonstrated leadership skills.Excellent communication and team building skills when interacting with personnel and stakeholders.Interpersonal and operational savvy, managing people challenges and stakeholder engagement.Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you.Commitment to Diversity & Inclusion:
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment.Compensation and Benefits Summary:
The pay range for this position at commencement of employment is expected to be between $107,200-$160,800/year. The total compensation package may also include other elements, including a sign-on bonus, restricted stock units, and various paid time off benefits.Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected.Accessibility & Reasonable Accommodations:
The Novartis Group of Companies are committed to providing reasonable accommodation to individuals with disabilities.Division: DevelopmentBusiness Unit: Innovative MedicinesLocation: USASite: East HanoverCompany / Legal Entity: Novartis Pharmaceuticals Corporation
#J-18808-Ljbffr