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Computer Validation Specialist
GEOGRAPHICAL WORKING LOCATION: AvTech Labs, Kalamazoo, MI
SPECIFIC ASSIGNMENTS:
COMPUTER VALIDATION PROJECT RESPONSIBILITIES:
- Lead Validation team to define, plan and schedule software validation activities, resource and execute validation activities within agreed upon milestones.
- Provide recommendations for computer validation activities on changes to validated systems.
- Provide recommendations on the activities that are necessary to retire a computer system.
- Provides technical consulting and project management functions as required.
COMPUTER VALIDATION METHODOLOGY RESPONSIBILITIES:
- Develop computer validation policies, procedures, and practices that comply with FDA regulations
- Provide insight and expertise on best practices in software quality for the site.
- Create policies and procedures to assure the consistent application of computer validation principles and tactics across the entire organization.
- Develop and implement a computer change control program.
- Provide input on developing network and security policies and procedures
- Develop with IT disaster recovery and back-up plans.
COMPUTER VALIDATION RESPONSIBILITIES:
- Provide technical expertise and support to departments requiring computer validation services.
- Participate in requirements analysis, workflow mapping, and the software selection process.
- Lead the development and creation of computer validation plans, risk analyses, and test plans
- Author and/or guide others in writing requirements, collating functional specifications, and making software configuration decisions for a software solution.
- Review of computer validation documentation for cGMP compliance, current regulatory compliance, validation, and quality expectations
- Author and/or guide others to establish/maintain test scripts and traceability matrices (from software requirements to test procedures) for computer validation projects.
- Guide validation team in executing test scripts, generating testing documentation, and creating test reports.
- Author and/or guide the creation of standard operating procedures for computer applications
- Author and/or guide the creation of user guides for computer applications
- Provide training and implementation plan support for computer applications, including writing training exercises and training manuals.
- Develop testing plans for the disaster recovery and back-up plans.
BACKGROUND:
- Minimum of 5 years of experience in related field
- BS or MS degree
- Excellent interpersonal and organizational skills.
- Excellent communication skills.
- Responsive problem solver and action oriented.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually quiet to moderate. Laboratory setting that involves glassware, hazardous chemicals, and others working in close proximity.
Some overtime may be required to meet laboratory and customer requirements
Mail resume: Eurofins Scientific, 6100 Thornton Ave., Suite 220, Des Moines, IA 50321
To apply for either of these positions, resumes should be sent to employment@eurofinsus.com.
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