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Job Details

Facilities Engineering Manager GMP Pharmaceutical

Company name
CreoSalus, Inc.

Louisville, KY

Date Last Verified
Feb 15,2018

Posted on
Feb 14,2018

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CreoSalus is looking for a cGMP Facilities Engineering Manager to work in Louisville, Kentucky. CreoSalus is a rapidly growing start-up life-sciences company focused on peptide manufacturing. The Facility Engineering Manager reports to the Chief Operations Officer and will oversee the maintenance, operation, and improvement of all facility cGMP process equipment, utility, mechanical and security systems. This individual will also be responsible for managing key GMP programs such as installation, commissioning, calibration, maintenance, and lifecycle management within a well-developed quality system for clinical and commercialized manufacturing.Responsibilities:· Establishes operational objectives and assignments to ensure effective management of facility operations and maintenance programs including: management of outside service providers, energy conservation, asset management, reliability centered maintenance, resource planning, life cycle costing, and identification and use of industry best practices and procedures.· Directs and coordinates the activities of the plant maintenance and engineering staff to start-up new utility & equipment systems, maintain compliance, and manage plant critical systems operation and qualification on an on-going basis.· Manage assets throughout their lifecycle from defining user requirements through decommissioning· Make recommendations for preventive maintenance programs, upgrades, and repairs· Assets will include facility spaces, cleanrooms, utilities, equipment, building automation· Interfaces with federal, state, and local regulatory authorities to manage projects requiring regulatory approval including the FDA, EMA, OSHA, EPA, and local authorities· Represents Facilities and Engineering function during FDA and other regulatory agency inspections by explaining design features of facility, utilities, and qualification methods· Write SOP's, Change Orders and Deviations based on solid understanding of regulatory requirements for the engineering function· Directly manage one or more engineers to accomplish functional objectives· Leader for educating on and supporting quality, safety, and environmental compliance· Partners with Quality Assurance, Manufacturing, Quality Control, Inventory Management and other groups to improve processes and asset performance· Performs management functions including performance management, as well as training and development of facilities maintenance and engineering employeesQualifications and Education: · Minimum Bachelor's Degree in Engineering (Mechanical, Chemical, or other engineering aligned discipline)· 5 years of experience working in pharmaceutical manufacturing engineering function· Must have strong understanding of MEP and utility systems as well as commissioning, qualification and validation activities.· Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP).· Should have familiarity with MS Office, MS Project, SAP\/Oracle, and sound accounting practices.Strong organizational skills, oral and written communication and team attitude.· Proven knowledgeable with pharmaceutical industry guidelines such as ISPE Baseline Guides, ISO and ASME BPE· Demonstrated ability to lead and manage functional teams (direct reports) as well as 3rd party service providers· Successful track record for cross-functional leadership, facilitation, project managementPreferred:· Knowledge of aseptic pharmaceutical processing regulations· Advanced understanding of contamination control topics including cleanroom operation, HEPA filtration, disinfection, gowning, and proper material\/personnel flow· Experience in current requirements for lifecycle management of GMP assets· Understanding of HVAC systems for pharmaceutical facilities· Experience with building automation, monitoring systems, asset management systems, security systems· Working knowledge of cGMP equipment such as lyophilizers, compressed air systems, Water for Injection grade water system, chilled water systems.

Company info

CreoSalus, Inc.

Company Profile

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