Validation Specialist – Biotech Downstream Process Equipment

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.    Key Responsibilities : Develop, review, and execute validation protocols (IQ, OQ, PQ) for downstream process equipment.
• Perform risk assessments, gap analyses, and validation reports for new and existing equipment.
• Collaborate with engineering, QA, and operations teams to ensure equipment meets regulatory requirements.
• Support commissioning and qualification activities for bioprocess systems, including filtration, chromatography, and centrifugation equipment.
• Review and approve validation documentation, SOPs, and change controls.
• Identify and implement continuous improvement initiatives in validation processes.
• Support regulatory inspections and audits, providing required validation documentation.

Qualifications :

Preferred Qualifications :

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.