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Validation Engineer
Rochester, NY, US
Engineering
Bachelors Degree
Full Time, Temporary
$49.50 max
Experienced (Non-Manager)
On-site
Medical Devices and Supplies
First Shift (Day)
Rochester, NY, US
$49.50 max
Experienced (Non-Manager)
Full Time, Temporary
Medical Devices and Supplies
On-site
Engineering
Bachelors Degree
First Shift (Day)
Job details
Kelly Engineering is hiring for a Validation Engineer role with a renowned Medical Device company in the Rochester, NY area. This Validation Engineer will be an integral part of the development process engineering team supporting all lab verification/validation needs. This position will be involved in all aspects of DPE IT projects and will support other lab equipment projects as needed. This is a long-term, contract role with competitive pay.
Responsibilities:
- Translate user needs into technical requirements and ensure the requirements are properly documented (user requirements specification, functional specification, etc.).
- Lead or assist programmers with appropriate software design documentation (design specifications, release notes, etc.).
- Develop appropriate testing strategies to confirm software meets the user and quality system requirements and is appropriately documented (test scripts, qualification protocols).
- Manage software/equipment/process qualifications and validations with generation of appropriate documentation.
- Coordinate data reporting strategies to meet business needs
- Provide support to Software Quality Assurance representatives during MES validation of change control process.
- Participate with the engineering and operations teams to define plans for integrating, standardizing, scaling and enhancing our products and the services utilized to deploy/install/release those products.
- Expand and develop site specific reports in the MES application including requirements capture, development, testing and deployment.
Requirements:
- Degree in Science/Engineering with Quality Engineering experience and/or certification as a Quality Engineer (or related role).
- 3-9 years’ experience in a technical role.
- Computer competent with SQL and Oracle.
Other Experience:
- Familiar with CFR Part 11 requirements, experience with change control requirements, experience with software development lifecycle.
- Communication, organization, report writing a must.
- Must be able to develop working relationships with various internal core competencies and work as a team member.
- Special Skills: Good understanding of software engineering practices, ISO-9000, GMP, medical device manufacturing experience, technical writing, equipment and software qualification and documentation, excellent communication skills.
9716066
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