Commissioning & Qualification Specialist
Commissioning & Qualification Specialist
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Job Description
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:
- Collaborate with C&Q Engineers to develop and maintain commissioning and qualification procedures and documents.
- Write review and approve C&Q protocols and reports for various systems (e.g. HVAC utilities production equipment lab equipment).
- Execute commissioning and qualification activities for plants and equipment.
- Coordinate with external consultants and internal resources to ensure timely document generation and execution.
- Manage change controls and deviations related to plants and equipment.
- Support maintenance and calibration functions to improve compliance and quality.
- Provide expertise in troubleshooting and root cause investigations.
- Facilitate the transfer of technical knowledge across units and sites.
Qualifications Requirements/Knowledge/Education/Skills:
- Bachelors or Masters degree in Chemical Engineering Pharmaceutical Technology or a related scientific field.
- At least 2 years of experience in GMP manufacturing relevant to the area of expertise.
- Proficiency in English; additional language skills are a plus.
- Strong understanding of regulatory requirements and quality standards.
- Excellent analytical problem-solving and communication skills.
- Ability to work collaboratively in a team environment.
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirn consideracin para el empleo sin importar raza color religin sexo orientacin sexual identidad de gnero informacin gentica 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.
Required Experience:
Manager
Employment Type
Full-Time
