Manufacturing Equipment Validation Specialist

RCM Technologies • United States, United States • 19h ago

FULL TIME CONTRACT Title: Manufacturing Equipment Validation Speciaist Location: Barceloneta, Puerto Rico (100% On-Site) Contract Length: 6+ Months with the possibility of extension Position Summary: RCM Technologies is looking for a Manufacturing Equipment Validation Specialist responsible for planning, executing, and documenting all qualification and validation activities for equipment, facilities, utilities, and processes within the Oral Solid Dosage (OSD) manufacturing area. This role ensures compliance with cGMP regulations (FDA, EMA) and guarantees that all systems consistently produce high-quality, safe, and effective pharmaceutical products (tablets and capsules). Responsibilities:

OSD Equipment Qualification: Design, write, and execute Installation (IQ), Operational (OQ), and Performance (PQ) protocols for all OSD manufacturing machinery, including high-shear granulators, fluid bed dryers, tablet presses, and tablet coaters.

Process Validation (PPQ): Lead and manage Process Performance Qualification (PPQ) studies for new and commercial OSD products, ensuring critical process parameters (CPPs) and critical quality attributes (CQAs) are consistently met.

Cleaning Validation SME: Develop, execute, and report on Cleaning Validation studies for OSD product contact equipment to demonstrate effective removal of product residue and prevent cross-contamination.

Change Control Management: Serve as the Validation Subject Matter Expert (SME) on the Change Control System, assessing the impact of proposed changes to OSD equipment or processes and defining necessary revalidation strategies.

Deviation and Investigation: Investigate and resolve validation-related deviations, non-conformances, and Out-of-Specification (OOS) results, applying formal Root Cause Analysis (RCA) methodologies and implementing CAPAs.

Regulatory Compliance: Ensure all validation practices, documentation, and executed work adhere to U.S. FDA, Puerto Rico, and international cGMP regulations and Client corporate standards.

SOP and Documentation Control: Author, review, and approve Standard Operating Procedures (SOPs), technical reports, and Validation Master Plans (VMPs) for OSD systems.

Audit Support: Provide direct support during regulatory and internal audits by presenting and defending OSD qualification and validation documentation to inspectors and auditors.

Qualifications

Professional Experience: Minimum of 3-5 years of hands-on experience in equipment and process validation within the regulated pharmaceutical or biotechnology industry.

OSD Experience: Direct, demonstrable experience with the validation lifecycle of Oral Solid Dosage (OSD) equipment and processes.

cGMP Knowledge: Thorough working knowledge of 21 CFR Part 211 (cGMP for Finished Pharmaceuticals) and current industry best practices.

Bilingual Fluency: Fluent in both English and Spanish (written and verbal) is required to support site operations, documentation, and cross-functional communication.

Statistical Analysis: Proficiency in applying basic statistical methods (e.g., capability analysis, sampling plans) for validation data evaluation.

Technical Writing: Excellent technical writing and documentation skills required to produce accurate, concise, and audit-ready validation records.

Education : Bachelor's Degree in an Engineering discipline (Chemical, Mechanical, Electrical, Industrial) or a related Scientific field (e.g., Pharmacy, Chemistry). 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.

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