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Associate Director/Director Facility Engineering & Automation

Company: Arrowhead Pharmaceuticals, Inc.
Location: Verona
Posted on: May 26, 2023

Job Description:

The PositionThe Associate Director/Director of Facility Engineering & Automation will provide leadership to all phases of automation and engineering projects from concept through implementation. They will serve as the technical lead and support the specification, installation, utilization, qualification, and improvement of manufacturing processes and utility equipment supporting the Verona facility. They will work collaboratively with multiple functional areas such as Manufacturing, Process Engineering, Quality, EHS, Facility Maintenance, Development, and Supply Chain, to achieve goals. They will lead the metrology program for instruments and equipment with a regulatory impact at the site and ensure process automation utilized for GMP manufacturing activities is properly implemented and maintained.Responsibilities* Provide expertise in engineering, design, installation and start-up of equipment and automation systems in a GMP manufacturing environment* Develop short and long-term strategies to support manufacturing automation, process improvements and technology solutions that support business efficiencies and fit compliance standards* Collaborate with manufacturing operations in problem solving with regards to existing and new systems* Provide technical and managerial leadership for the calibration and facility engineering team, including development plans, training, and performance evaluations* Ensure instrument calibration work is completed in a timely manner* Stay up to date on and make recommendations based on latest technology trends and best practices* Ensure Blue Mountain Regulatory Asset Manager (RAM) system remains up-to-date and accurate for equipment and instrument inventory as well as for maintenance* Identify opportunities for greater efficiencies through process improvements, standardized utilization, increased user adoption and satisfaction, and robust data integrity and compliance* Manage facilities, utilities, and GMP manufacturing drawings to maintain current versions* Oversee implementation and updates to the PLC Process Monitoring & Control System (PMCS), including management of third-party vendors for system programming* Maintain appropriate pest control and management programs for the overall facility* Manage the generation of user requirements specifications (URS) as well as equipment and utility commissioning and qualification activities. Participate in the evaluation of emergency and planned changes to qualified equipment/utilities. Track requalification requirements and schedules* Ensure compliance with FDA, ICH, and other applicable regulatory bodies with respect to GMP laboratory and process equipment/instrumentation maintenance and calibration* Establish and manage project budgets* In partnership with QA, ensure vendors utilized in support of GMP related activities are appropriately evaluated and qualified according to written procedures* Act as the facility/equipment subject matter expert (SME) for internal and external regulatory audits of the Verona GMP manufacturing facilityRequirements:* Bachelor's degree in engineering or related science field* At least 10 years of experience in maintaining facilities/utilities supporting pharmaceutical manufacturing and testing* Knowledge and experience with application of GMP regulations in a manufacturing environment* Excellent leadership skills* Excellent communication skills* Strong skillset and knowledge of Metrology and CalibrationPreferred:* Understanding of general physical and chemical hazards present in a pharmaceutical production environment* Previous use with Veeva QualityDocs or other electronic document management system* Prior experience using Procore or other drawings management application* Understanding of phase appropriate application of GMP regulations for clinical development as well as commercial GMP facility expectations* Current Professional Engineer (PE) licenseCompensation DescriptionThe base salary range for this position in the selected city is $150,000 - $225,000 annually.

Keywords: Arrowhead Pharmaceuticals, Inc., Madison , Associate Director/Director Facility Engineering & Automation, Executive , Verona, Wisconsin

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