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Plastikon Healthcare is looking for a Engineering Project Manager who will manage and provide technical direction for process, system, and equipment changes, implementation of new systems, equipment, and product/process transfers, as assigned. The Engineering Project Manager researches new processes and suggests improvement for continued excellence and provides assistance on troubleshooting existing processes and equipment. This position participates in continuous improvement and Kaizen projects in support of the Quality System.

Job Roles required of the position:

  • Facility Maintenance: Supports Managers with technical direction for set-up and troubleshooting of equipment, systems, and processes. Actively review reports and documents for compliance to requirements and troubleshoots issues. Provides hands-on training on various systems. Ensures that all critical systems operate in a validated state.
  • Engineer & Validation: Represents engineering and validation for new systems and equipment by providing technical information, writing, and review of URS documents. Directs engineering efforts on new or changing processes, equipment, and systems. Manages engineering and validation efforts for FAT and SAT commissioning activities. Manages and directs the generation and execution of protocols for qualification events. Manages, writes, reviews, and revises procedures to support new systems or new product realization projects. Maintains professional and technical knowledge by attending educational workshops and reviewing professional publications.
  • Purchasing: Uses the purchasing system to procure equipment, systems, and supplies.
  • DCR System: Actively uses the DCR System to change or add new document requirements.
  • CIMP System: Assists Managers and leads projects for continuous improvement and Kaizen events.
  • NCR System: Supports the nonconformance system through reporting of Nonconformances and supporting Quality in investigation activities. Provides reports and communication based on investigation findings.
  • Training: Provides training to other employees to support continued competency.
  • Other duties as assigned.

EDUCATION / EXPERIENCE:
Minimum Requirements: BS in Engineering or another Scientific discipline with equivalent experience, 4+ years hands-on experience with facility equipment, processes, and systems. Experience in engineering project management, ISO Quality Systems, commissioning and qualification preferred and is used to determine job level (I-IV).

Skills/Qualifications: Project Management, Performance Management, Staffing, Management Proficiency, Coaching, Developing Standards, Process Improvement, Decision Making, Troubleshooting, Quality Management, Project coordination and management, P&ID reading, CAD or similar engineering software, commissioning and qualification principles, ISO Systems.

LANGUAGE SKILLS: Required reading, writing and speaking fluently in English and preparing reports.

PHYSICAL DEMANDS: While performing the responsibilities of the job, the employee is required to talk and hear. The employee is required to sit, stand, walk, reach with arms and hands, lift objects, and use their hands and fingers, to handle or feel. The employee is occasionally required to climb or balance, stoop, and kneel, crouch or crawl. Vision abilities required by this job include close vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT: While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vehicles. The employee is exposed to laboratory chemical reagents and microbial cultures. The noise level in the work environment is usually quiet to moderate; some activities require personal protective equipment, which is provided. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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