Sr. Manager, Engineering, Maintenance & Facilities

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* Essential Duties and Responsibilities:

** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
* Ensures all aspects of engineering and facilities are adhering to cGMPS and PCI’s established SOPs. Makes the necessary recommendations and changes to improve process efficiencies.
* Ensures all projects are executed safely, on time, and within budget.
* Identifies, prepares and leads site CAPEX projects.
* Responsible for all aspects of Engineering, Instrumentation and Controls, Utilities, Facilities, and Maintenance programs.
* Determine appropriate equipment, line, tooling, costs and capacities for new projects or changes to existing projects.
* Instill a strong culture of Lean and Continuous Improvement through the use of the site maturity index.
* Oversees the departmental budget and headcount
* Provides coaching, mentoring and development to each direct report both in execution of their group responsibilities and in their own development.
* Provides leadership to ensure engineering and facilities support manufacturing operations in a fashion that focuses on quality and adherence to the maintenance schedule in support of Operations
* Directs general and specialized maintenance, CAPEX projects, facility renovation, construction, and repair of grounds, buildings, equipment, utility systems, at all manufacturing, warehousing and office facilities within the Madison, WI site.
* Support a variety of regulatory and client audits.
* Ensures team compliance with all corporate policies and procedures.
* Provides guidance to people managers in the areas of compliance, safety, deviations, corrective and preventive actions, and investigations related to engineering, maintenance, and facilities areas.
* Works closely with key functions such as Quality, Manufacturing, EH&S, Sales/Project Management, Global Engineering, and Global PMO to ensure internal and external clients’ requirements are met.
* Analyzes existing processes/unit operations and determine modifications necessary to improve safety, as needed and streamline processes.
* Responsible for on time calibration and preventive maintenance schedules for 1300+ site assets including fill line equipment, clean utilities, and laboratory equipment.
* Advanced knowledge and understanding of PLC programming and integration that support GMP automated system, vial transport equipment, clean utilities, sterilization equipment, and lyophilizers.
* Supports Continuous improvement activities tied to budget goals and helps lead key ESG initiatives.
* Directs assigned personnel, including performance evaluations, scheduling, orientation and training. Recommends employee hires, transfers, promotions, salary changes, discipline, terminations and similar actions, as appropriate.
* Maintains the professional competence, knowledge and skills necessary for the satisfactory performance of all assigned responsibilities.
* Provides leadership in analyzing and developing improvements in process efficiency, quality, safety and client relationships (internal and external).
* Correctly implements industry best practices that will successfully withstand regulatory inspections by regulatory authorities.
* Responsible for administration of Computerized Maintenance Management System (CMMS) and maintenance planning.
* Part of the Site Leadership Team (SLT).
* Performs other duties as assigned.
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* Qualifications:

** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Bachelor’s degree in engineering discipline preferred.
* Master’s degree in engineering or business administration preferred.
* Operational background in cGMP environment, preferably in aseptic manufacturing/engineering.
* Demonstrated skill in managing a diverse population of professional, technical, and hourly personnel as well as external resources.
* Experience in working with regulators during…