Full Time Contract Title or Role: Validation Engineer Location: Arecibo, Puerto Rico, 100% on-site Length of Contract: Minimum ten (10) months Company Description: Our client specializes in the manufacturing of cardiovascular medical devices and is in the process of transferring a new product. Position Description: The Validation Engineer will develop, execute and final reporting of the equipment qualification and product validations related to the technology transfer of a new medical device. Will also review the product transfer related documentation. Responsibilities:

• Develops and executes validation protocols and reporting.

• Develops, organizes, analyzes, and presents interpretation of results for the validation 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.

  Qualifications:

• Experience in IQP/OQP/PQP developing, execution and reporting.

• Experience in reviewing e quipment calibration and preventive maintenance specifications.

• Experience in process/product validation protocols development and execution. Molding Qualification a plus.

• Experience in performing statistical analysis: Normality, tolerance limits, capability and gage R&R tests.

• Knowledge of component qualification and software validation.

• 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.

  Education & Certifications:

• Bachelor's degree in mechanical, electrical of industrial engineering.

• Minimum 5 years' experience within the GMP regulated industry performing similar tasks.

  About RCM: RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America. Equal Opportunity Statement: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job, duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.