Process Validation Consultant

Job Description

LOCATION: Gurabo / Juncos / Las Piedras

We are seeking an experienced Process Validation Consultant to support a pharmaceutical manufacturing facility in the central/ East area of Puerto Rico. The consultant will lead and execute validation activities for new and existing processes in compliance with FDA, EU, and other international regulations. This is a contract-based opportunity for an independent professional with expertise in process validation, cGMP requirements, and technology transfer within pharmaceutical and consumer health operations.

Main responsibilities:

Develop and execute process validation protocols (IQ/OQ/PQ) for manufacturing and packaging processes.

Create and review validation master plans, risk assessments, and validation summary reports.

Support process scale up for new or reformulated products.

Ensure validated processes meet cGMP and regulatory standards (FDA, EU, ICH).

Collaborate with engineering, quality assurance, manufacturing, and regulatory teams to optimize process performance and resolve deviations.

Prepare summary reports.

Implement and oversee continued process verification (CPV) to maintain process control post qualification.

Review and manage validation related deviations, change controls, and CAPA activities.

Support cleaning validation and equipment/utilities qualification as applicable.

Other related activities.

General requirements:

Fluency in Spanish and English (spoken and written)

Strong technical writing and documentation skills.

Ability to work independently and manage multiple priorities.

Proficiency in Microsoft Office 365 (Excel, Word, Power Point) and project management tools.

Organizational skills, attention to detail, and ability to manage multiple tasks.

Excellent communication skills.

Education Requirements:

Minimum: Bachelor's degree in engineering, Life Sciences, Chemistry, Biology, or related field.

A combination of education and relevant experience can be considered.

Experience Requirements:

5+ years of experience in process validation within pharmaceutical or consumer health manufacturing.

Proven knowledge of cGMP, FDA, ICH, and other regulatory requirements and guidance.

Physical requirements

Ability to sit for long periods of time.

Light physical activity may be required occasionally.

You should be able to visit field locations as needed.

Must be able to use personal protective equipment (PPE) when required.

Ability to perform in diverse industrial environments.