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Experience Level
Mid to Senior
Qualifications
Bachelor's degree in Engineering (Computer Science, Chemical, Mechanical, Electrical, etc.) is required.3-5 years of hands-on validation experience, including the writing and execution of validation protocols. Able to work independently with minimal supervision and communicate effectively with project team members to ensure deadlines are met. Excellent technical writing and communication skills are necessary. Proficiency in Microsoft Office applications (Word, Excel, Project). Strong interpersonal and problem-solving skills are essential. Demonstrated excellence in documentation practices and meticulous attention to detail.
About the job
Proven experience in Cleaning Validation is essential.
In-depth knowledge of a Risk-Based Approach to Commissioning and Qualification practices.
Skilled in planning and integrating Commissioning and Qualification activities specifically in medical device manufacturing, with a preference for Class II products.
Expertise in Risk Management practices including Assessments, Functional Risk Documents, and pFMEA.
Experience with equipment qualification and process validation is required.
Familiarity with Computerized System Validation (PLC, HMI, etc.) is a must.
Understanding of 21 CFR Part 11 requirements and the ability to incorporate these into an effective testing strategy.
Assist in investigating deviations and resolving issues encountered during field activities.
About Validation & Engineering Group, Inc.
Validation & Engineering Group, Inc. is a premier services provider offering innovative solutions to the Pharmaceutical, Biotechnology, Chemical, and Medical Device industries. Our expertise encompasses Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and more, ensuring our clients achieve their regulatory and operational objectives.
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Utilize a Risk-Based Approach to enhance Commissioning and Qualification practices in medical device manufacturing, particularly for Class II products.Develop and coordinate Commissioning and Qualification activities effectively throughout the manufacturing process.Conduct comprehensive Risk Management practices, including assessments, Functional Risk Documents, and pFMEA.Oversee equipment qualification and process validation to ensure compliance and efficiency.Implement Computerized System Validation for PLC, HMI, and related systems.Ensure adherence to 21 CFR Part 11 requirements by integrating them into a streamlined testing strategy.Support deviation investigations and resolve issues encountered during execution activities in the field.
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