PCI Pharma Services · 3 days ago
Sr. Manager, Engineering, Maintenance & Facilities
Madison, WI
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
8+ years expPCI Pharma Services is dedicated to life-changing therapies and has a global impact in the biopharma industry. The Sr. Manager of Engineering, Maintenance & Facilities is responsible for overseeing all engineering and facilities functions, ensuring compliance with cGMP standards, and leading continuous improvement initiatives within the organization.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
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
Qualification
Required
Bachelor's degree in engineering discipline 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
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
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. Setting future leadership for success
Performance measurement and KPI Tracking and Reporting
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
Preferred
Master's degree in engineering or business administration preferred
Experience in working with regulators during inspections/audits is highly desired
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
Proficiency with MS Office suite is preferable
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase