Equipment Qualification Specialist

Job Description

Job Posting Title

Equipment Qualification Specialist (Sterile Manufacturing)

Location: Manatí, PR - On Site

We are seeking Equipment Qualification Specialists with a strong focus on sterile areas equipment qualification within the pharmaceutical industry. This role will primarily support IQ/OQ/PQ activities for manufacturing equipment, ensuring compliance with regulatory requirements and internal quality standards.

This is a contract-based opportunity for a professional willing to work on-site at client facilities.

Main Responsibilities

Lead and execute equipment qualification activities (URS, IQ, OQ, PQ, traceability matrix) for pharmaceutical manufacturing equipment used in sterile manufacturing areas.

Develop, review, and approve qualification protocols and reports with emphasis on process equipment (e.g., filling lines, blisters, cappers, lyophilizes, utilities tied directly to manufacturing).

Ensure all qualification activities comply with cGMP, U.S. Food and Drug Administration requirements, and internal procedures.

Perform and document installation verification, functional testing, and performance qualification of manufacturing equipment.

Support risk assessments (e.g., FMEA) related to equipment qualification.

Manage and support deviations, investigations, and CAPAs associated with equipment qualification activities.

Initiate and support Change Control processes, ensuring proper impact assessment on qualified equipment.

Collaborate with Manufacturing, Engineering, Validation, and Quality teams to ensure equipment readiness and compliance.

Maintain accurate documentation including protocols, test scripts, reports, and SOPs, ensuring full traceability.

Support requalification and lifecycle management of manufacturing equipment.

General Requirements

Fluent in Spanish and English (spoken and written).

Strong knowledge of documentation practices and data integrity.

Proficiency in Microsoft Office 365 (Excel, Word, PowerPoint, Teams, SharePoint).

Strong technical writing and communication skills.

Ability to work in a cross-functional team environment.

Detail-oriented with strong problem-solving skills.

Education Requirements

Bachelor’s Degree in Engineering, Life Sciences, or related field.

Experience Requirements

Minimum 3 years of experience in equipment qualification within the pharmaceutical industry.

Proven hands-on experience executing IQ/OQ/PQ for manufacturing/process equipment (REQUIRED).

Strong understanding of validation lifecycle, risk management, and qualification principles.

Experience with deviations, investigations, and CAPA processes.

Exposure to facilities or commissioning activities is a plus, but not the primary focus.

Physical Requirements

Ability to sit for extended periods.

Occasional light physical activity.

Ability to work in manufacturing environments and use PPE as required.

Compensation

Compensation will be based on experience.