Computer System Validation Manager Jobs in Niles, IL

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

An engineering professional that works with project owners, automation engineers, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified automated systems equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The primary objective is to design and execute robust evaluation, testing, and documentation strategies that support risk management, commissioning, and validation in alignment with product, regulatory, and quality requirements. The role also contributes to optimizing automated systems, process controls, and related technical workflows that support reliable and compliant manufacturing operations

Responsibilities

• Work with end users, project engineers,  and system owners to develop User Requirements Specifications and Functional/Design Specifications for new or modified facilities, utilities, and HVAC systems.
• Support Factory Acceptance Testing and related verification activities to confirm facility and utility systems meet defined requirements prior to site deployment.
• Identify risk controls, critical elements, and traceability of design requirements based on FMEA or other risk assessment approaches for qualified facilities and utility systems.
• Develop and execute commissioning, qualification, and validation protocols for facilities, utilities, HVAC systems, and environmental/viable monitoring systems to ensure performance against specifications and intended use.
• Perform minor troubleshooting of issues encountered during commissioning, including control logic, integration, instrumentation, documentation, and qualification deliverables.
• May support project activities such as project leadership, development of operational procedures, training of maintenance/technical staff/operators on new equipment and utilities, reviewing new or modified documentation for compatibility with qualified systems, and implementing changes to equipment parameters or facility-related settings.
• Support execution of risk management activities, including periodic review and update per the Validation Master Plan, interface with best practices and ccRA, and understanding of risk management principles, trace controls, change impact assessments, and rating scales. May perform FMEA authorization/facilitation as needed.
• May serve as a QRM facilitator commensurate with responsibility.
• Work with contract validation resources as part of a team to support timely completion of qualification activities within assigned area of responsibility.

• Bachelor’s Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 1+ years of significant engineering and/or operational experience
• Experience in the development of commissioning, qualification, validation or risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
• Experience with Computer System Validation (CSV) is required.
• 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
• Experience working with automation systems, controls, PLC/SCADA, instrumentation, or computer-based process controls strongly preferred.
• A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
• Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
• Works with junior or contract team members as part of a team
• Ability to manage multiple projects (3+) simultaneously

​Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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