Bilingual Validation Specialist – Lab Equipment (GMP)

RCM Technologies, Inc.; Jayuya (PR); On-site; USD 55,000 - 96,000; Full time

Job summary

RCM Technologies, Inc. is seeking a Validation Specialist to develop, execute, and report on manufacturing equipment validation/qualification protocols at our Puerto Rico facility.

The six-month contract requires strong experience in GMP-regulated environments, statistical analysis, protocol development, and cross-functional collaboration with manufacturing, process development, utilities, facilities, and labs.

Qualifications

• Experience in IQP/OQP/PQP developing, execution and reporting.
• Experience in reviewing equipment calibration and preventive maintenance specifications.
• Experience in performing statistical analysis: Normality, tolerance limits, capability and gage R&R tests.
• Knowledge of computer system validation life cycle (validation plan, traceability matrix, URS, risk assessments).
• Good Technical writing skills.
• Must be fully Bilingual (English/Spanish) and must have good communication skills both oral and written.
• Experience working in a regulated environment.
• Demonstrated interpersonal skills, including the ability to listen, resolve problems, deal with unresolved issues, delays and unexpected events, and the ability to effectively communicate and maintain rapport with supported customers.

Responsibilities

• Develops and executes validation protocols and reporting.
• Develops, organizes, analyzes, and presents interpretation of results for the equipment qualification projects of significant scope and complexity.
• Employs advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise.
• Applies knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.
• Develops technical solutions to complex problems requiring the regular use of ingenuity and creativity.
• Works with manufacturing, process development, utilities, facilities, labs in developing requirements and recommendations for large and/or highly complex processes, system/facility modifications.
• Works with project managers to complete the validation responsibilities of engineering projects within schedule, budget, and quality constraints.
• Ensure compliance with all company procedures and all applicable regulatory agency requirements.

Skills

IQP/OQP/PQP

Calibration review

Statistical analysis

CSV life cycle

Technical writing

Bilingual English/Spanish

Regulated environment

Customer communication

Education

Bachelor's degree in science or engineering

Job description

RCM Technologies, Inc. is seeking a Validation Specialist to develop, execute, and report on manufacturing equipment validation/qualification protocols at our Puerto Rico facility.

The six-month contract requires strong experience in GMP-regulated environments, statistical analysis, protocol development, and cross-functional collaboration with manufacturing, process development, utilities, facilities, and labs.