New City, New York
Facilities Equipment & Controls Engineer
Our client is seeking a Facilities Equipment & Controls Engineer within our Technical Operations team. They are a global leader with decades of success in the development of health dispensing solutions. This company has been setting the standard for drug delivery medical devices and we continue to break new ground providing innovative devices, components and services that enable the success of our clients and improve the health of patients. If you are curious, enjoy challenges and a fast-paced environment, we are the next step in your career!
This Facilities Equipment & Controls Engineer will focus on providing technical manufacturing support for existing processes and for developing and introducing new processes and equipment from conception through qualification.
What You Will Do:
• Work with the Facilities Management Team to Develop and also Manage projects o Financial Budget o Plan o Coordinate o Consult o Advise o Learn
• Optimize Process yield and productivity through continuous improvement programs.
• Manager pharmaceutical technical transfers including all relevant activities that need to be performed to manufacture, control and measure product quality.
• Manage and direct outside vendors and contractors
• Manage project budgets by maintaining statistical and financial records
• Supervise engineering and technical staff participating on project teams
• Assist in the design of new equipment, processes, procedures and systems
• Purchase and install new or transferred equipment
• Arrange and lead in the overhauling of existing equipment
• Investigate manufacturing problems to diagnose to root cause and recommend lasting solutions
• Make continuous improvements to current systems and operations to enhance efficiency
• Plan and organize maintenance activities
• Provide technical management, maintenance, and development of new and existing production lines and automated processes.
• Commission new equipment using well planned, documented, and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the Production Department that results in a safe and functional environment that meets established design requirements and stakeholder expectations.
• Participate as a key member in technology transfers and process validations
• Understand CMMS and OEE software, to help organize and assemble data, assign action items and identify areas of weakness or omission for improvement and
• Establish through calculation and analysis production capacities
• Ensure compliance with all applicable specifications, standard operating procedures (SOPs), and FDA regulations
• Comply with current Good Manufacturing Practices.
• Document actions
What we are Looking For:
▪ BS in Mechanical Engineering Industrial Engineering or Electrical Engineering
▪ At least 2 years of experience in Medical Device Manufacturing, Pharmaceutical, or FDA regulated environment in Facilities related roles
▪ Knowledge and experience operating under OSHA standards
▪ Knowledge of or trained in Lean Manufacturing / Six Sigma
▪ At least 5 years of experience with third-party vendors, contractors and service providers required
▪ Demonstrated experience managing a biotech facility, including a combination of manufacturingng, research, and office space. Experience scaling operations and building new space is preferred.
▪ Strong project management and organizational skills ▪ Knowledge of and experience with:
– CMMS – Computerized Maintenance Management System
– Compressed Air
– Process Instrumentation
– Industrial Operations
– Maintenance Operations
– OEE – Overall Equipment Efficiency
– Electrical, plumbing, carpentry, compressor and HVAC experience.
– Utilizing SAP and MS Office.
– Thorough understanding of cleanrooms and cGMP.
– Ability to read blue prints/schematics and to use shop tools
▪ Results driven! Hands-on, roll-up-your-sleeves approach with high sense of urgency
▪ Excellent communication and inter-personal skills. Proven experience with diplomacy with all stakeholders and the ability to build strong relationships
▪ Detail oriented, rigorous, analytical, reactive, and good interpersonal skills.
▪ Executing PFMEA/FAT/SAT/IQ/OQ/PQ
▪ Generate technical documentation for Maintenance Operations such as work instructions for production processes
▪ Train staff Supervise operator training
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