How will you make an impact?
What will you do?
This position directly supports and assists the Sr Manager Operations / Site Leader in providing facilities, engineering, construction and quality systems technical expertise for GxP compliance aspects of facility operations and maintenance. This includes providing Engineering and Project Management of improvement projects for Facilities Mechanical, Electrical, Piping (MEP), Utilities, HVAC and Refrigeration infrastructure operations and maintenance. The position will assist in improving departmental quality systems within the site Quality program and help lead the compliance activities for the Miami, FL facilities in support of GxP site operations across multiple shifts.


How will you get here?
Education and Experience

• Bachelor of Science degree from an accredited college or university in an Engineering discipline.
• Bachelor of Science degree from an accredited college or university in an Engineering discipline.
• 7+ years’ experience in engineering with 3 years’ experience managing major infrastructure upgrade projects preferably in the regulated manufacturing facility / cGMP industry.
• 5 years’ experience in the operations and maintenance of industrial utility systems.
• Knowledge of Building Management / Automation System (BMS / BAS) and industrial process control automation systems is required.
• Experience with design, cost estimation, assistance in preparation of capital appropriation packages, coordination of the review and approval process, authorization, and execution of site infrastructure capital projects through construction, startup, commissioning and turnover to ensure project technical, budget, and schedule requirements are met.
• Provide technical support for equipment/system replacement, expansion, efficiency improvements and facility energy usage and energy reduction projects.
• Provide technical engineering support and GxP compliance aspects for operation and maintenance of all facility infrastructure equipment/systems in a safe, environmentally compliant, cost effective and reliable manner, including steam, heating hot water and chilled water systems, compressed air, HVAC, refrigeration and auxiliary systems to ensure continuous production/availability and meet the site demands.
• Supports the development of SOP’s, system impact assessments, criticality assessments, risk assessments and validation protocols for modified or new facility equipment and utilities, new functionality/process, process/equipment changes and modifications and scheduled requalification/revalidation.
• Assures compliance and provides technical direction for Facilities Change Control (CC) activities with QA, and Validation to ensure changes are implemented after appropriate evaluation, approval and testing in accordance with site procedures.
• Addresses challenges such as utility or other facility systems failures with significant impact on GxP, failures or problems related to operating or maintenance needs, and significant observations during audits.
• Develop and maintains constructive relationships with site management and peers at all levels. Interface daily with Operations, Facilities and Quality on the status of plant operations, maintenance and work requirements.
• Manage special projects as assigned by management.

Knowledge, Skills, Abilities

• A comprehensive knowledge of facility mechanical and electrical system infrastructure, utility generation, operations and distribution, including boilers, air compressors, chillers, cooling towers, water treatment, electrical, generators, HVAC Systems, and piping systems is required.
• Must have proven capability in project engineering, project management, budget management and contract administration.
• Must work directly with the site management, operational departments, Quality, internal technical resources, and external technical resources to solve problems using their analytical, technical compliance, and human relations skills.
• Must have excellent communication and administrative skills to coordinate with diverse site customers.
• Computer literacy with standard MS software to provide management reports, budget tracking and energy usage is required. Past experience with TrackWise and Document Control Systems, AutoCAD, BMS / BAS, and Computerized Maintenance Management Systems (CMMS) is required.
• Must have strong analytical skills and ability to interpret blueprints, AutoCAD, P&ID and other technical documents.
• Must be able to multitask and respond to shifting priorities.
• Must have strong organizational skills.
• Must have strong influencing skills.
• Must be driven and results oriented.
• Advanced degree in Engineering or related discipline desirable.
• LEED, Energy Manager Certification or Professional Engineer designation is desirable.
• Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.

Physical Requirements

• Must be able to stand frequently (50% - 79%)
• Must be able to walk frequently (50% - 79%)
• Must be able to sit (up to 49%)
• Must be able to lift and or carry the max of 50 pounds frequently (25%-50%)
• Must be able to bend frequently (50%-79%)
• Must be able to squat (up to 15%)
• Personal Protective Equipment Certification (PPE) including but not limited to filtering face masks, PAPR, N-95 masks, half face masks and safety glasses is required to perform this position.
• Must be able to enter both heat / cold environments