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The senior manager is accountable for all aspects of Engineering, Instrumentation and Controls, Metrology, Utilities, Facilities, and Maintenance in supporting pharmaceutical product manufacturing across the PCI Madison, WI site. The senior manager provides leadership to ensure the highest level of quality and adherence to cGMPs across the site. This role is responsible for managing people, providing quality and technical direction, and actively participating in driving and developing strategies for continuous improvement within the department.
Job Responsibility:
Accountable for all aspects of Engineering, Instrumentation and Controls, Metrology, Utilities, Facilities, and Maintenance in supporting pharmaceutical product manufacturing across the PCI Madison, WI site
Provides leadership to ensure the highest level of quality and adherence to cGMPs across the site
Responsible for managing people, providing quality and technical direction, and actively participating in driving and developing strategies for continuous improvement within the department
Manages and oversees all areas of process engineering, automation, calibration, facilities, operation of utilities including HVAC, buildings and ground maintenance, and maintenance of utilities and facilities supporting aseptic operations
Responsible for management of site CAPEX projects and acts as site representative for PCI’s Environmental, Social, and Governance program
Ensures all aspects of engineering and facilities are adhering to cGMPS and PCI’s established SOPs
Ensures all projects are executed safely, on time, and within budget
Identifies, prepares and leads site CAPEX projects
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
Directs general and specialized maintenance, CAPEX projects, facility renovation, construction, and repair of grounds, buildings, equipment, utility systems
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
Analyzes existing processes/unit operations and determine modifications necessary to improve safety and streamline processes
Responsible for on time calibration and preventive maintenance schedules for 1300+ site assets
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
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
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)
Requirements:
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 inspections/audits is highly desired
8+ years of experience in the field of technical engineering support to biopharma/pharm and/or medical device facilities
8-10 years of experience in management of professional and technical staff with accountability for objectives and subsequent evaluation
5-8 years of experience with engineering and maintenance support to biopharma/pharm and/or medical device facilities
5 years of experience managing subordinate people leaders with accountability for objectives and subsequent evaluation
Experience with company financial systems and an understanding of accounting practices and financials a plus
Experience with direct exposure to Customers in a CDMO business is a plus
Demonstrate commitment to continuous improvement at all levels within the organization
Excellent organizational skills
Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines
Excellent verbal and written communication skills
Ability to effectively manage multiple projects, teams and technical staff at all levels
Ability to assess and develop organizational talent which includes engaging employees and driving technical and personal development
Performance measurement and KPI Tracking and Reporting
Proficiency with MS Office suite is preferable
Possess advanced leadership competencies which support the rigidity of GMP operations against the competing demands of a CDMO environment
Leads by example to motivate and engage through clear communication, of vision and goals
Demonstrates resilience and takes a proactive approach to change management to enable leaders to drive the change successfully
Effective verbal and written communication with both internal and external contacts is critical to success
Oversees a wide array of subordinate managers, supervisors, and technicians across multiple shifts
Set a clear vision and direction for the reporting functions, encouraging communication and a team-based approach
Nice to have:
Experience with company financial systems and an understanding of accounting practices and financials
Experience with direct exposure to Customers in a CDMO business