Job Summary:

The Validation Specialists team will support process validation and cleaning validation activities for a technology transfer project in a pharmaceutical manufacturing environment. This role involves developing technical documentation for change control, process validation and cleaning validation as well as performing sampling and handling in compliance with regulatory standards.

Key Responsibilities:

• Develop, execute, and review process validation protocols (IQ, OQ, PQ) for technology transfer projects, also reports and master plans.
• Define and monitor critical process parameters and critical quality attributes.
• Support process performance qualification for new and existing products.
• Prepare and maintain technical documentation for change control, validation reports, and regulatory submissions.
• Conduct sampling activities in assigned areas, ensuring proper handling and documentation in a regulated environment.
• Collaborate with manufacturing, quality assurance, regulatory, and engineering teams to ensure validation compliance.
• Analyze validation data, identify trends, and recommend improvements to optimize manufacturing processes.
• Ensure compliance with GMP, FDA, and industry regulations related to validation activities.
• Support audits and inspections by providing validation documentation and technical expertise.
• Assist in troubleshooting and resolving validation-related issues during technology transfer.

Qualifications & Experience:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 3-5 years of experience in process validation within a pharmaceutical or regulated manufacturing environment.
• Strong understanding of GMP, FDA, and ISO regulations related to validation and technology transfer.
• Experience in change control documentation and validation lifecycle management.
• Hands-on experience with sampling techniques and regulatory handling procedures.
• Excellent analytical, problem-solving, and technical writing skills.
• Ability to work independently and collaboratively in a cross-functional team.

Preferred Skills:

• Knowledge of statistical analysis tools for validation data interpretation.
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Familiarity with risk assessment methodologies in validation processes.

Work Methodology:

• Professional services contract
• 6-12 months of project assignment with potential extension
• Administrative shift Monday to Friday, 8am - 5pm with availability to support activities in non-standard hours
• On-site job in Las Piedras - Puerto Rico
• Languages: Spanish and English (verbal and written)