The ideal candidate is someone who has good documentation review skills as this role will be focused on integration of the old quality management system into the new quality management system. If they have been part of an integration, that is fantastic.
Ideally, they would have some background in equipment as well, specifically IQ/OQ/PQ as we re-write and execute equipment qualifications per new procedures. Experience with a line move or duplication would be a great example of that.
Qualifications:
Excellent documentation skills
High attention to detail
General mechanical engineering knowledge with the ability to quickly step into the initiative after training
Excellent documentation and execution skills
Education: Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering.
Experience: 3-5 years Prior experience preferred
Duties:
Review documentation of procedures and ensure proper execution of protocols and SOPs as part of the site’s integration into Client.
Support the maintenance of controlled process documentation, including work instructions, process flow diagrams, gap analysis, control plans, and risk management documentation.
Exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company's environment to take an effective and proactive leadership role in a specific technical manufacturing discipline.
Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks that may have multiple inter-coordinating elements.
Expectation that the individual will be able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required.
Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components.
Interaction with peers and mentors on the individual's projects is generally in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities.
Ideally, they would have some background in equipment as well, specifically IQ/OQ/PQ as we re-write and execute equipment qualifications per new procedures. Experience with a line move or duplication would be a great example of that.
Qualifications:
Excellent documentation skills
High attention to detail
General mechanical engineering knowledge with the ability to quickly step into the initiative after training
Excellent documentation and execution skills
Education: Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering.
Experience: 3-5 years Prior experience preferred
Duties:
Review documentation of procedures and ensure proper execution of protocols and SOPs as part of the site’s integration into Client.
Support the maintenance of controlled process documentation, including work instructions, process flow diagrams, gap analysis, control plans, and risk management documentation.
Exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company's environment to take an effective and proactive leadership role in a specific technical manufacturing discipline.
Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks that may have multiple inter-coordinating elements.
Expectation that the individual will be able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required.
Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components.
Interaction with peers and mentors on the individual's projects is generally in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities.