As an FDA Validation Engineer at JR Automation, you will work with our internal and customer teams to guide and help solve complex challenges within the custom automation world. The projects we work on offer diverse experiences that strengthen and challenge individual and team skills, resulting in innovative solutions. We value creativity, assertiveness, quick thinking, and a general love for learning. Sound good? Come think, solve, and create with us!
What You’ll Do:
- Provide FDA validation guidance during equipment design, software design, build, debug, and qualification phases of a project.
- Write overall project quality (validation scope) plans.
- Organize, guide, and write requirement specifications as necessary.
- Review qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies.
- Interface with internal and client validation and engineering teams to secure document approvals.
- Oversee and execute validation qualifications at our facility and at the customer’s site.
Note: This list of responsibilities is by no means inclusive; however, it is intended to be a guideline for activities.
What You’ll Bring:
- Minimum two-year degree required
- Bachelor of Science degree in Systems Engineering, Life Sciences, Electrical/Controls Engineering, or Quality Assurance or equivalent preferred
- Minimum of one year performing validation activities (three or more years' experience preferred)
- Experience in custom engineered solutions, Medical Devices, or Life Sciences is preferred
Skills You’ll Have:
- Experience working with electrical design drawings
- Proficient in Microsoft Office
- Experience working in a GAMP 5 based validation model
- Excellent presentation skills and ability to mentor without direct authority
- Experience with Rockwell Automation PLC Control Systems is preferred
- Experience debugging/working with custom machines is preferred
- Travel to customer sites for installation and startup of equipment; up to 25% travel expected yearly.
- Ability to work in a team environment
- Self-starter, able to work with minimal guidance