What are the responsibilities and job description for the Engineer I, Quality Systems (Computer System Validation) position at Axogen?
Job Summary of the Engineer I, Quality Systems (Computer System Validation)
The Engineer I, Quality Systems will provide support to IT and business system owners on the design, execution, and review of computer system validations (CSV) and data integrity (DI) assessments. This role is further responsible for the creation, revision, and review of controlled documents relating to CSV and data integrity. This role will provide quality engineering and quality assurance support for all Axogen sites and departments, ensuring compliance with applicable standards and regulations.
Requirements of the Engineer I, Quality Systems (Computer System Validation)
- Minimum of Bachelor of Science Degree in Biomedical, Mechanical Engineering, Engineering Technology or similar required
Minimum one year of experience in the pharmaceutical or medical device industry required - Working experience with computerized systems in regulated industries and 21 CFR Part 11 compliance is preferred
- Ability to exercise creativity and judgement
- Excellent oral and written skills
- Excellent intrapersonal and team building skills
- Well-organized, with the ability to efficiently manage multiple, competing priorities
Responsibilities of the Engineer I, Quality Systems (Computer System Validation)
The specific duties of the Engineer I, Quality Systems include but are not limited to:
- Review of draft and executed validation deliverables to ensure compliance with Axogen procedures and applicable regulatory requirements
- Collaborate with system and process owners on completing validation and data integrity risk assessments
- Support the drafting and review of changes, deviations, periodic reviews, and associated quality records concerning computerized system and/or data integrity issues
- Participate in risk assessments supporting investigations and process improvements
- Contribute to validation planning for new systems and processes
- Write and revise procedures and controlled documents governing CSV/DI by collaborating with IT, QA, and applicable departments
- Develops and/or delivers training on CSV/DI to applicable personnel
- Supporting internal and external audits and inspections
- Other duties as assigned by manager
- This role will involve up to 25% travel
Location
13631 Progress Blvd., Alachua, FL 32615
OR
111 West Oak Ave., Tampa, FL 33602
OR
913 Industrial Drive Place, Vandalia, OH 45377
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