Validation Engineer

MUSTS:

-Bachelor's Degree in Engineering

-3+ years of validation engineering experience in a manufacturing environment

-experiencing creating and establishing test protocols for equipment

PROS:

-experience in regulated market (med device, pharmaceutical, FDA, etc.)

JOB DUTIES:
- Implement policies and procedures to validate/qualify equipment, computer systems, and processes in accordance with regulatory requirements and company standards
- Coordinate, direct and lead validation efforts, including equipment, process, and computer system validation
- Design, develop and execute test scripts from software requirements for computer system validation
- Generate, execute, review and complete validation documentation required, such as Traceability Matrix, URS, IQ/OQ/PQ protocols and summary reports
- Compile and analyze validation data and maintain validation documentation
- Develop and maintain a requalification schedule for facilities, equipment, and processes based on a risk assessment, current industry "best practices" and regulatory requirements
- Management and oversight of the change control program for the facility
- Facilitate and/or support validation training, change control, periodic review of validated systems, equipment and processes
- Interface with management personnel to represent QA/Validation in project teams, with the objective to assure that project quality objectives are met
- Provide technical decision making regarding cGMP compliance, regulatory issues, validation strategy and quality systems and/or strategic activities

About Aerotek:

Our people are everything. As a Best of Staffing® Client and Talent leader, Aerotek® Inc. has distinguished itself as a leader in recruiting and staffing services, by having a deep understanding of the intersection of talent and business. As a strategic partner to more than 17,000 clients and 300,000 contract employees every year, Aerotek's people-focused approach yields competitive advantages for its clients and rewarding careers for its contract employees. Headquartered in Hanover, Md., Aerotek operates a network of over 230 non-franchised offices with more than 6,000 internal employees dedicated to serving our customers. Aerotek is an operating company of Allegis Group, a global talent solutions provider. To learn more, visit .

Aerotek is acting as an Employment Agency in relation to this vacancy.