Senior Validation Specialist

FULL TIME CONTRACT

Title : Senior Validation Specialist

Location : Barceloneta, Puerto Rico (% On-Site)

Contract Length : + Months (Full-Time) with the possibility of extension

Company Description :

Join a dynamic team at a leading small molecule contract manufacturing organization in Barceloneta, Puerto Rico. Our client specializes in a wide range of pharmaceutical manufacturing capabilities, including massing, granulation, direct compression, hot melting extrusion, bi-layer tablets, tablet coating, capsules, particle coating, and liquids.

Position Summary :

RCM Technologies is looking for a highly experienced Senior Manufacturing and Utilities Validation Specialist for a contract role. The specialist will be crucial in ensuring that all manufacturing processes and critical utility systems meet strict regulatory standards and Good Manufacturing Practices (cGMP). We're looking for a detail-oriented expert who can independently handle validation projects from planning to final reporting.

Responsibilities :

• Validation Execution : Execute validation activities for manufacturing equipment and critical utility systems.
• Documentation : Author, review, and approve validation documentation such as Validation Master Plans (VMP), protocols (IQ / OQ / PQ), and final reports. Ensure all documentation is accurate, complete, and in compliance with regulatory requirements.
• Deviation Handling : Investigate and resolve deviations and non-conformances discovered during validation activities. Propose and implement corrective and preventive actions (CAPAs).
• Technical Expertise : Serve as a subject matter expert on validation principles and practices for cross-functional teams, including engineering, quality assurance, and operations.
• Lifecycle Management : Ensure the validated state of equipment and systems is supported throughout their lifecycle through periodic reviews and requalification activities.
• Regulatory Compliance : Stay current with all relevant industry guidelines and regulatory requirements (, FDA, EMA) to ensure all validation efforts are compliant.
• Collaboration : Work closely with project teams, vendors, and regulatory bodies to ensure a smooth and complaint validation process.

Qualifications

Education :

About RCM :

RCM is a leading provider of Business, IT, and Engineering Services to over , 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.