Overview
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and TikTok.
Responsibilities
* Lead site Automation team within our pharmaceutical operation, reporting into the Digital Systems organization. Responsible for the design, implementation, maintenance and optimization of control systems and automation technologies across the facility.
* Support a Safe working environment by aligning with environmental health, safety & maintenance program practices, rules, and regulations.
* Collaborate with cross-functional teams including Operations, Quality, IT and Maintenance.
* Manage and support control systems including standalone manufacturing equipment, system upgrades, data migrations for DCS, PLCs, SCADA, and Data Historian systems.
* Ensure all automation systems comply with regulatory requirements (FDA, cGMP, etc.).
* Mitigate risk within functions through sound design, early risk assessments and implementation of fallback strategies.
* Recommend and implement business strategies and engineering controls to reduce costs, increase efficiency, and drive world-class performance.
* Develop and manage staff through hiring, managing performance, developing talent and providing clear expectations.
* Provide technical leadership for day-to-day operational shift support for Upstream and Downstream Drug Substance manufacturing.
* Oversee troubleshooting, upgrades and lifecycle planning of automation systems.
* Maintain documentation including functional specifications, validation protocols and change controls.
* Experience in change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities.
* Work with vendors and contractors for automation related projects and support.
* Lead and support Capital projects. This role involves applying advanced automation engineering principles in the design, specification, construction, startup, commissioning and qualification of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles.
* Executive presence and the ability to communicate complex automation topics in simple terms at various partner forums in the workplace.
* As a System SME, be accountable and responsible to provide necessary support during internal and external regulatory audits.
Qualifications
* Bachelor’s degree in computer science or related discipline with a minimum of twelve (12) years of relevant experience required. Master’s degree in computer science, Engineering, or related discipline with a minimum of ten (10) years of relevant experience required.
* 10+ years’ experience developing and maintaining automation software and equipment and PLC systems in a manufacturing environment; AI and machine learning experience.
* Working experience administering and/or configuring Distributed Control Systems (DCS) such as Emerson DeltaV, Foxboro I/A, OSI PI, Rockwell PLC is required.
* Direct experience with system development and validation, including development of system specifications (DS, FS, URS) and risk-based validation strategies, and validation protocol development and execution.
* Demonstrated knowledge of 21 CFR Part 11, ISA, Data Integrity requirements for automated systems in the pharmaceutical industry.
* Some familiarity with Industry 4.0 technologies and digital transformation.
Additional Information
* 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.
* This job is eligible to participate in our long-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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, visit https://www.abbvie.com/join-us/reasonable-accommodations.html
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