What are the responsibilities and job description for the Validation Engineer - Rochester, NY position at Unicon Pharma Inc?
Job Description
Job Description
Summary :
Client is looking for a Validation Engineer for 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
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a Validation Engineer - Rochester, NY?
Sign up to receive alerts about other jobs on the Validation Engineer - Rochester, NY career path by checking the boxes next to the positions that interest you.
