Contract Validation Specialist — QA & Process Compliance

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 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