Sr. Manager, Engineering, Maintenance & Facilities

Senior Manager, Engineering, Instrumentation, and Controls

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in people who make an impact, drive progress, and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective: 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. 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. Additionally, responsible for management of site CAPEX projects and acts as site representative for PCI's Environmental, Social, and Governance program.

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.

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 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. Setting future leadership for success.
• 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.
• <10% domestic and some international.

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future.

Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.