The purpose of this position is to ensure relevant equipment and processes are validated and remain in a validated state.
Principal Duties & Responsibilities
Provide validation documentation and execution expertise, support and guidance to necessary departments.
Assist in building systems, processes, and a culture to sustain a validated state.
Through validation activities, work as part of the team to create, execute and summarize validation projects necessary to support areas in manufacturing.
Help ensure manufacturing compliance with Quality System Regulations and company policies and procedures as applicable to equipment qualification and process validation.
Coach and mentor other manufacturing engineers to develop people who are trained in process validation methodology according to company practices and FDA requirements.
Support Subject Matter Experts (SME’s) with regard to developing and completing validation documents.
Communicate effectively with all levels of personnel within company.
Review adequacy of validation documentation and objective evidence supporting validation activities.
Manage multiple projects/tasks simultaneously.
Perform other duties as assigned.
Expected Areas of Competence
Excellent oral and written communication skills and coaching skills are required.
Demonstrated knowledge and proficiency in writing and executing validation plans and protocols (IQ/OQ/PQ or other industry equivalent terminology).
Working knowledge of using Statistical Process Control (SPC), Design of Experiments (DOE), and process capability studies as applicable to validation activities.
Highly self-motivated individual with the ability to work as part of a team is essential to the job. A background in production operations is also beneficial.
Must be computer literate with a working knowledge of Microsoft Office products.
Experience in medical devices or other regulated industries is preferred.
Education/Experience Requirements
Minimum of Bachelor’s degree (4 year accredited university degree) required. Degree preferred in science, biomedical or mechanical engineering, other Engineering Sciences (technical) or a combination of education and experience. Minimum 3.0 GPA.
Location
Warsaw, Indiana
Other Requirements/Restrictions
Must be willing to complete Background/Criminal history check & Drug Screen, Confidentiality Agreements, and Non-Disclosure/Employment Agreements.
Company Description:
Allegiant International LLC is a nationally certified woman-owned & operated business, with a base of operations located in Auburn, Indiana. Allegiant operates two business divisions, both of which strive to achieve the Companies Mission of "being an indispensable resource for our clients and a globally recognized source of superior personnel".
