Manager, Facilities and Metrology

Role Overview

• Ensures all aspects of facilities and metrology are adhering to cGMPS and PCI’s established SOPs.
• Make the necessary recommendations and changes to improve process efficiencies.
• Ensures all projects are executed safely, on time, and within budget.
• Responsible for all aspects of facilities and calibration programs.
• Oversee 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 facilities and calibration supports manufacturing operations in a fashion that focuses on quality and adherence to the schedule in support of Operations.
• Assures compliant and timely completion of all quality documents (Deviations, CAPAs, Change Controls, etc.) assigned to the facilities and calibrations team.
• Support a variety of regulatory and client audits.
• Ensures team training and performance 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 facilities and calibration areas.
• Works closely with key functions such as Quality, Manufacturing, EH&S, Sales/Project Management, Engineering, and Global PMO to ensure internal and external clients’ requirements are met.
• Analyzes existing processes/unit operations and determines modifications necessary to improve safety, as needed and streamline processes.
• Responsible for on time calibration schedules for Madison site.
• Advanced knowledge and understanding of PLC programming and integration.
• Direct assigned personnel, including performance evaluations, scheduling, orientation and training.
• Recommends employee hires, transfers, promotions, salary changes, discipline, termination 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.

Requirements

• 5+ years of experience in the field of technical facilities or metrology in the biopharma/pharm and/or medical device facilities and proven leadership experience.
• Bachelor’s degree in engineering, chemistry, biology, or related technical discipline or equivalent combination of work experience and schooling/certifications.
• 3+ years management/leadership experience.
• Operational background in cGMP environment, preferably in aseptic manufacturing / facilities.
• Demonstrated skill in managing a diverse population of professional, technical, and hourly personnel as well as external resources.
• 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
• Experience in the Management of 5+ people
• 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.

Benefits

• Health insurance
• Paid time off
• Professional development opportunities