Process Validation Consultant

Job Description

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.