Validation Specialist

Kelly® Engineering is seeking Validation Specialist for contract position at manufacturing client in Arroyo, Puerto Rico. If you’re passionate about bringing the latest professional discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring.

• Continuously comply with all applicable regulations and industry standards.

• Analyzes assembly issues and identify, test and implement the most effective solutions in a timely manner as result of supplier change requests

• Responsible to stop further processing in the event of encountering non-conforming products condition.

• Conducts analysis on variables within the unit (e.g. rework, scrap, etc.) and address recurring issues as appropriate.

• Designs and/or implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment, based on statistical process control, incoming part/product inspection criteria, automated testing, functional gauging, and productivity improvements.

• Assess supplier’s proposed design, build and/or recommendation of fixtures, equipment and tools to ensure quality of our products, at minimal costs.

• Develops or update reports and documentation related to suppliers processes (MAPs, MTRs, fixture database, etc.).

• Comply with all safety and environmental standards applicable to the area.

• Submits periodic reports on assigned topics to appropriate personnel.

• May train others in Quality Assurance/GMP/FDA-QSR related topics, as a result of supplier changes

• Interact with suppliers and Customer SMEs about process, material, specification changes, answer general product questions, develop and standardize inspection methods and or techniques to ensure components compliance with specifications. Assists vendors in resolving manufacturing and quality issues. Conduct, review or approve supplier validations related to process changes, materials, specifications, manufacturing transfer, etc. as applicable

• May aid in the new product development process by identifying effective and efficient assembly techniques and manufacturing processes to be used.

Requirements

BD in Engineering

Previous experience related

• TMV (test method validation)
• Creation of SOPs
• Protocols and reports on IQ/OQ/PQ
• Supplier component process validations or PPAPs
• Execution of validation runs, training, etc
• Process development.
• Experience in New Product Introduction not required but if available is prefer.

What happens next:

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Engineer recruiters will have access to your profile, making your opportunities limitless.