Validation Specialist – Water System & Equipment Qualification

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities:

• Performed assigned validation and documentation activities under supervision, ensuring accuracy and compliance with established procedures.
• Executed documentation deliverables including SCA, GxP Risk Assessment, Risk Rating, IOQ Protocols, Final Reports, SOPs, PM documentation, and automation specifications in compliance with cGMP and regulatory requirements.
• Provided technical support to ensure installation, qualification, and automation integration activities complied with corporate and regulatory standards.
• Prepared, reviewed, and maintained all required validation and engineering documentation.
• Reviewed and updated SOPs, work instructions, and forms to align with regulatory and operational requirements.
• Ensured all deliverables met project objectives and stakeholder expectations.
• Supported coordination with cross-functional teams including validation, engineering, and automation personnel.
• Demonstrated a customer-focused approach by proactively identifying risks and ensuring effective communication of project status.
• Ensured high-quality deliverables by maintaining accuracy, completeness, and compliance across all documentation.
• Maintained professional collaboration with internal teams and stakeholders to support project execution.
• Monitored project progress, tracked documentation status, and incorporated feedback to ensure alignment with requirements.
• Identified and supported process improvements and documentation efficiency opportunities.
• Communicated issues and deviations promptly, providing recommendations and supporting resolution activities.
• Participated in project execution by contributing technical expertise in validation and automation documentation.
• Complied with administrative requirements including documentation control, versioning, and record management.
• Maintained knowledge of regulatory standards including cGMP, FDA requirements, and CFR Part 11.
• Performed additional tasks related to installation, including piping tie-ins, equipment replacement, system integration (PLC/HMI updates), and removal of obsolete control points.

---

Qualifications / Requirements / Knowledge / Skills:

• Bachelor’s degree in Engineering, Science, or related technical field (or equivalent experience).
• Experience in regulated industries, including pharmaceutical manufacturing and utility systems.
• Strong knowledge of cGMP, FDA regulations, validation lifecycle, and quality systems.
• Hands-on experience in validation documentation (SCA, Risk Assessments, IOQ, SOPs, PM, and technical reports).
• Experience supporting automation and control system documentation (URS, Design Specifications, Alarm Assessment).
• Knowledge of CFR Part 11 and data integrity requirements.
• Strong analytical, organizational, and problem-solving skills.
• Effective written and verbal communication skills.
• Customer-focused mindset with ability to work in cross-functional teams.
• Proficiency in Microsoft Office tools and documentation systems.
• Bilingual (English/Spanish).

 

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.