Project Engineer in Augusta, GA at APEX Systems

Date Posted: 8/14/2019

Job Snapshot

  • Employee Type:
    Contractor
  • Location:
    Augusta, GA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/14/2019

Job Description

Job #:  969989
The Project Engineer will support the implementation of labeling management system projects working in cooperation with rebranding activities, documentation changes, and contractor management. The documentation activities may include feasibility studies, validation protocols, standard operating procedures changes, training material, drawings, raw material specifications updates etc. This resource will manage the site timeline for the project and will participate in the project management activities.
Responsibilities:
  • Accountability of UDI Classified Project and transition projects and project activities resulted of the integration with the Quality System.
  • Engage with suppliers and manage all external responsibilities.
  • Interface with local and external departments to drive the Change Documentation Package for the different project implementation phases.
  • Interface with manufacturing departments and equipment vendors to develop and execute validation protocols for new equipment as well as to create/modify training procedures.
  • Support on training to the manufacturing personnel about the new process functioning.
  • Complex administrative activities including managing project tasks, composing letters and reports, preparing / editing presentations, and recommending or making purchase decisions are included in the responsibilities of this role. 
  • Provides support to the equipment commissioning.
  • Assist production areas on equipment and process problems during the implementation phases.
  • Work as an integral member of project team during the project implementation phases. 
  • Follow all certified standards, GMP, OSHA, plant policies and procedures
  • Sets the standard for timeliness, work ethic, and personal integrity

Qualifications:
  • B.S. Mechanical or Electrical Engineering preferred
  • 5 years of experience preferably in a medical manufacturing industry.
  • Understanding of FDA regulations surrounding the manufacture of medical devices, GMPs, and process validations.
  • Project management experience a must
  • Experience with manufacturing environment and automated machines
  • Pharmaceutical experience is considered a plus.
  • Experience with printing systems and labeling management systems preferred
  • Experience with change documentation package.
  • Ability to write clear and concise Test Protocols and Procedures
  • Good written and verbal skills
  • Knowledge of modern computer programs to include project management software and strong computer skills in MS office suite (Excel, Word, Project etc.)
  • Ability to express ideas both in written and oral communications.
  • Ability to coordinate with different people who have different priorities and agendas to accomplish the task at hand.
  • Ability to deal with contractors in order to assist them with the equipment process commissioning. 
  • Excellent interpersonal and reasoning skills.
  • Knowledge of design engineering tools such as AutoCAD, standard machine shop processes, and specialty shop capabilities.
  • Positive attitude and result-oriented person.
  • Ability to manage multiple task in a high paced environment and willing to adapt and address scope changes. 

 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.