Validation Specialist – Biotech Downstream Process Equipment

3 days ago

United States Mentor Technical Group Full time

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:

  • Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, or related field.

  • Minimum 3–5 years of experience in validation of biotech downstream process equipment.

  • Strong knowledge of cGMP, FDA, and ICH guidelines.

  • Experience with IQ/OQ/PQ protocols and validation documentation.

  • Familiarity with downstream processes such as chromatography, filtration, and centrifugation.

  • Excellent problem-solving, communication, and organizational skills.

Preferred Qualifications:

  • Advanced degree in relevant scientific field.

  • Experience in a multi-site or global biotech environment.

  • Knowledge of computerized systems validation (CSV) and automated process control systems.

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.

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