Computer Systems Validation Engineer
G R Validation & Compliance Services, Inc., is a full service Validation, GMP Compliance, Engineering, Equipment Design consulting and staffing firm dedicated to serve the FDA regulated Pharmaceutical, Biotechnology and Medical Device industries. We are currently looking for validation engineers (3) with solid medical device validation experience for a 6+ months project in Ann Arbor, MI. Below is the job requirement. · Validation Specialist is responsible for planning, scheduling, execution and leading validation project assignments. Participate in cross-functional project teams in the development and implementation of the validation plan and protocols. · Schedule, plan, manage and execute installation, operation and performance qualifications for computerized systems for manufacturing, laboratory, utility systems and equipment in accordance with cGMP, Good Engineering Practices (GEP) · Perform I/O testing (dry loop and wet loop testing). · Validate software interface for medical device instruments per 21 CFR Part11 and CFR 820 requirements. · Author Computer system validation test scripts for end user testing. · Assist troubleshooting computer systems when needed. · Prepare test summary reports and author deviations. · Author user requirements and design requirement documents based on customer input. · Participate in the design team and design control process from requirements development and design planning to design transfer. · Participate the design team in the development of verification and validation planning and execution. Education and Experience: · Bachelor’s or higher degree in Engineering or the life sciences or other related field. Minimum of 5 years of validation experience in a highly regulated environment: medical device, pharmaceutical, biotechnology or related industry. · Minimum of 3 years experience in the validation and qualification of manufacturing/packaging equipment qualification, computer systems validation, utility systems qualification or process validation. · Lean Manufacturing, CQE or Six Sigma certification preferred. · Thorough understanding of Software Life Cycle and GAMP “V” Model for validation. · Strong knowledge and understanding of applicable regulatory and quality requirements in an FDA-regulated environment and knowledge of 21 CFR Part 11. · Ability to manage, organize and troubleshoot complex technical problems. Strong problem- solving skills. · Results-oriented with ability to adapt to changing priorities. If you are interested, please send your resume to email@example.com Please mention your expected hourly rate.
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