Project Manager - CQV Biotech

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 : Collaborate with C&Q Engineers to develop, review, and maintain commissioning and qualification procedures and documentation.

Write, review, and approve C&Q protocols and reports for various systems, including HVAC, utilities, production, and laboratory equipment.

Plan, coordinate, and execute commissioning and qualification activities for plants and equipment.

Manage project timelines, resources, and deliverables, ensuring alignment with client expectations.

Coordinate with external consultants and internal teams to ensure timely document generation and protocol execution.

Oversee change controls and deviations related to plant operations and equipment performance.

Support maintenance and calibration functions to enhance compliance and operational quality.

Provide technical expertise for troubleshooting, root cause investigations, and continuous improvement initiatives.

Facilitate the transfer of technical knowledge across units, departments, and sites.

Qualifications / Requirements : Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Technology, or related scientific discipline.

Minimum of 2 years of experience in GMP manufacturing and C&Q activities within the biotech or pharmaceutical industry.

Strong knowledge of regulatory requirements, GMP standards, and quality systems.

Proven project management skills, including planning, coordination, and execution of technical projects.

Excellent analytical, problem-solving, and communication skills.

Ability to work effectively in a collaborative, cross-functional team environment.

Proficiency in English; additional language skills are a plus.

Preferred Skills : Experience with FDA, EMA, or other regulatory inspections.

Familiarity with software tools used in C&Q documentation and project management.

Strong organizational skills and attention to detail.

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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