Validation Specialist

Kelly Science, Engineering, Technology & Telecom; Arroyo (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Kelly® Engineering in Arroyo, Puerto Rico, seeks a Validation Specialist for a contract position at a manufacturing client. The role focuses on validation activities (TMV, IQ/OQ/PQ) and ensuring compliance with GMP/FDA-QSR standards, while supporting supplier process validations and PPAPs.

Responsibilities include analyzing assembly issues, designing inspection methods, developing reports (MAPs/MTRs), training teams, and interfacing with suppliers and customer SMEs to ensure product quality and

Qualifications

• BS in Engineering is required.
• Previous experience in validation/quality roles is required.
• TMV, SOP creation, IQ/OQ/PQ protocols and reports are required.
• Supplier component process validations or PPAPs are required.
• Experience executing validation runs and training is required.
• NPI familiarity is a plus.

Responsibilities

• Ensure compliance with regulations and industry standards.
• Analyze assembly issues and implement effective supplier-change solutions.
• Stop production when non-conforming products are encountered.
• Design and implement inspection/testing methods for precision/reliability.
• Assess supplier designs/fixtures for quality at minimal cost.
• Develop/update reports (MAPs, MTRs, fixture database) related to supplier processes.
• Train others in QA/GMP/FDA-QSR topics as needed.
• Interact with suppliers and Customer SMEs on changes; resolve quality issues.
• Conduct/approve supplier validations related to process changes, materials, and manufacturing transfers.

Skills

TMV (test method validation)

SOP creation

IQ/OQ/PQ protocols/reports

Supplier validations/PPAPs

Validation runs & training

NPI familiarity

Education

B.S. in Engineering

Job description

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.

• 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
• Experience in New Product Introduction not required but if available is prefer.