BioSpace
Overview
Manager, Automation Engineering- Onsite role at BioSpace. AbbVie seeks a result-driven leader to head the site Automation team within the Digital Systems organization. This role is responsible for leading the design, implementation, maintenance and optimization of control systems and automation technologies across the facility. Responsibilities
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, performance management, talent development and 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. Apply 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 business language at partner forums. Provide system SME support during internal and external regulatory audits. Qualifications
Bachelors degree in computer science or related discipline with a minimum of twelve (12) years of relevant experience; Masters degree with a minimum of ten (10) years of relevant experience. 10+ years experience developing and maintaining automation software and equipment and PLC systems in a manufacturing environment; AI and machine learning experience. Experience administering and configuring Distributed Control Systems (DCS) such as Emerson DeltaV, Foxboro I/A, OSI PI, Rockwell PLC. Direct experience with system development and validation, including DS/FS/URS development and risk-based validation strategies, and validation protocol development and execution. Knowledge of 21 CFR Part 11, ISA, and data integrity requirements for automated systems in the pharmaceutical industry. Familiarity with Industry 4.0 technologies and digital transformation. Compensation & Benefits
The compensation range described is the base pay range the Company believes in good faith it will pay for this role at the time of posting. Individual compensation may vary by geographic location and other factors. Benefits include paid time off, medical/dental/vision insurance and 401(k). Eligible employees may participate in short-term and long-term incentive programs. AbbVie is an equal opportunity employer. Veterans/Disabled. Reasonable accommodations available; see company links for more information. Seniority level: Mid-Senior level Employment type: Full-time
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Manager, Automation Engineering- Onsite role at BioSpace. AbbVie seeks a result-driven leader to head the site Automation team within the Digital Systems organization. This role is responsible for leading the design, implementation, maintenance and optimization of control systems and automation technologies across the facility. Responsibilities
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, performance management, talent development and 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. Apply 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 business language at partner forums. Provide system SME support during internal and external regulatory audits. Qualifications
Bachelors degree in computer science or related discipline with a minimum of twelve (12) years of relevant experience; Masters degree with a minimum of ten (10) years of relevant experience. 10+ years experience developing and maintaining automation software and equipment and PLC systems in a manufacturing environment; AI and machine learning experience. Experience administering and configuring Distributed Control Systems (DCS) such as Emerson DeltaV, Foxboro I/A, OSI PI, Rockwell PLC. Direct experience with system development and validation, including DS/FS/URS development and risk-based validation strategies, and validation protocol development and execution. Knowledge of 21 CFR Part 11, ISA, and data integrity requirements for automated systems in the pharmaceutical industry. Familiarity with Industry 4.0 technologies and digital transformation. Compensation & Benefits
The compensation range described is the base pay range the Company believes in good faith it will pay for this role at the time of posting. Individual compensation may vary by geographic location and other factors. Benefits include paid time off, medical/dental/vision insurance and 401(k). Eligible employees may participate in short-term and long-term incentive programs. AbbVie is an equal opportunity employer. Veterans/Disabled. Reasonable accommodations available; see company links for more information. Seniority level: Mid-Senior level Employment type: Full-time
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