Manufacturing Qualification / Validation Specialist

RCM Technologies • United States, United States • 2w ago

Full Time Contract Title or Role: Manufacturing Qualification / Validation Specialist (Entry Level) Location: Jayuya, Puerto Rico, 100% on-site Length of Contract: Six months Company Description: Our client specializes in the manufacturing of medical serums and bags and is in the process of validating new manufacturing equipment and their process controls. Position Description: TheEntry Level Manufacturing Qualification / Validation Specialist will assist in the developing, execution, and the preparation of final reports of the manufacturing equipment / process and qualification / validation protocols. Responsibilities:

Assist in the development and execution of qualification / validation protocols and reporting.

Develops, organizes, analyzes, and presents interpretation of results for the equipment qualification projects.

Applies knowledge of principles and practices outside of area of expertise to broad variety of assignments in related fields.

Develops technical solutions to problems requiring the regular use of ingenuity and creativity.

Works with manufacturing, process development, utilities, facilities, labs departments in developing requirements and recommendations for 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:

IQP/OQP/PQP developing, execution and reporting knowlwdge.

Knowledge in reviewing equipment calibration and preventive maintenance specifications.

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

Desirable knowledge in 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.

Education & Certifications:

Bachelor's degree in science or engineering.

0-1 years' experience within the GMP regulated industry performing similar tasks.

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. 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.

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