Equipment Qualification Specialist

Job Description

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.