JOB SUMMARY:
Supporting ethylene oxide engineering operations in the Americas (Costa Rica, Mexico, the United States, and Canada, this individual is able to both independently and collaboratively develop the scope, schedule, and budget associated with system programming and controls projects, as well as effectively execute and complete the project safely, within budget, and on schedule. This position strongly supports facility operations, monitoring controls parameters, improving facility operations, and reducing unplanned downtime through improved control systems and life cycle management of aging systems. This individual must have extensive current hands-on and field experience and be aware of the requirements in a medical device or pharmaceutical plant environment. The job requires domestic and periodic international travel as per our business needs. This individual must have tact and diplomacy to work with our internal customers (Sales, Operations, EHS) who may often have different priorities to the project scope and schedule. A strong engineering background, with electrical or software engineering competency, is required for the successful candidate.
DUTIES AND RESPONSIBILITIES:
· Evaluate & implement Ethylene Oxide Sterilization process-related technology improvements/advances inclusive of controls.
· Work with the Regional Maintenance Managers to implement controls improvements
· Assist the Facility Maintenance Supervisors, General Managers, and Regional Maintenance Managers in troubleshooting facility controls-based problems and help develop solutions.
· Improve facility reliability by managing and monitoring system controls, and managing system lifecycles.
· Work with Project Managers, Technology Engineers, and Regional Maintenance Managers in a team approach to improving facility operations and systems.
· Manage installation projects and execute testing as needed to support objectives.
· Understand and be able to read and code programming logic into PLCs and Panelviews.
· Develop, review, approve and execute IQ and OQ, documentation as related to software validation practices as required in the medical and/or pharmaceutical environment while ensuring compliance to all applicable standards related to the technology including federal, state, and local regulatory codes, as well as customer, operations and corporate requirements.
· Execute projects utilizing available internal resources, as well as suppliers and key subcontractors, as required
· Provide strategic oversight & management of applicable process control systems – PLCs, HMI applications, across all technologies (focus on Ethylene Oxide) to ensure required upgrades to hardware and software are implemented and key project initiatives are supported.
· Develop, control, and critically monitor all cost, scheduling, quality, and safety activities related to capital projects.
· Liaison between different engineering groups – project management, controls, R&D, as well as EHS and Quality personnel to support engineering initiatives.
· Manage several projects simultaneously, ranging in value from approximately $10K to $2.5M.
WORKING EXPERIENCE:
· Experience in the Pharmaceutical or Medical Device Industry dealing with FDA and/or other regulatory bodies.
· Five or more years of current equivalent industrial control system integration experience.
· Extensive knowledge of PLCs (standard and safety); HMI/SCADA applications; hardware configuration; VSDs; basic manufacturing network architecture methodologies and instrumentation with Allen Bradley or Siemens product line.
· Executing in an environment requiring disciplined decision-making skills that consider and values project safety, quality, cost, schedule, and equipment performance requirements.
SUPERVISION GIVEN:
Direct supervision of subcontractors and dotted lines to other project engineers and facility maintenance supervisors and technicians.
EDUCATION REQUIRED:
BS in Engineering (Electrical Engineering or Automation Software Engineering preferred).
EXPERIENCE & SKILLS REQUIRED:
Technical degree with 5 plus years of experience. Knowledge of the sterilization process and controls architecture and programming logic is beneficial.
SPECIAL REQUIREMENTS:
· This position may require approximately 30-50% travel.
· Occasional overseas travel with some weekend travel may also be required.
· Position periodically may require some physically demanding tasks.
Our client is a global leader in comprehensive sterilization services for the medical device, pharmaceutical, food safety, and advanced applications markets. With their industry-recognized scientific and technological expertise they help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Our client offers their customers a complete range of outsourced terminal sterilization services, primarily using the three major sterilization technologies: gamma irradiation, ethylene oxide processing, electron beam irradiation, and other technologies including X-Ray and nitrogen dioxide. Their global integrated network includes 48 facilities in 13 countries to ensure they provide the flexibility and redundancy needed. Our client is committed to addressing the growing need for sterilization in many parts of the world and partnering with their customers to eliminate threats to human health.