CQV Specialist Upstream 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. 

Responsibilities: 

• Develop, review, and execute Commissioning, Qualification, and Validation (CQV) protocols for upstream process equipment (IQ, OQ, PQ).

• Support equipment design reviews and provide validation input during procurement and installation phases.

• Perform risk assessments and identify critical quality attributes (CQAs) and critical process parameters (CPPs).

• Document and report validation results, deviations, and corrective actions in compliance with internal procedures and regulatory standards.

• Collaborate with engineering, manufacturing, and quality teams to ensure seamless equipment qualification and process transfer.

• Maintain and update validation documentation for existing and new upstream process equipment.

• Support regulatory inspections and audits, providing necessary documentation and evidence of compliance.

• Provide training and guidance on equipment operation and validation procedures to team members.

Qualifications / Requirements:

• Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related field.

• Minimum of 3-5 years of experience in CQV for upstream bioprocess equipment in pharmaceutical or biopharmaceutical industry.

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

• Experience with bioreactors, fermenters, cell culture systems, and related upstream equipment.

• Proficiency in protocol writing, validation reports, and deviation management.

• Strong analytical and problem-solving skills.

• Excellent communication and team collaboration skills.

• Ability to manage multiple projects and meet tight deadlines.

Preferred:

• Experience with single-use systems and advanced upstream bioprocess technologies.

• Knowledge of automation, SCADA systems, and process control.

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.