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 and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.  SUMMARY With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems. FUNCTIONS Applied Process Expertise 1. Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. 2. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities. 3. Provide troubleshooting support. 4. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process. Process Monitoring 1. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations. 2. Provide support of timely execution of the process monitoring quarterly reports. Non-Conformance and CAPA 1. Ensure that all Non-conformances are triaged within the established goal. 2. Responsible for authoring investigation reports. 3. Responsible for execution of corrective actions. 4. Responsible for managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process Validation 1. Assist with generation of process validation protocols and reports. 2. Assist with the execution of the process validation. 3. Support collection and analysis of process validation data. Regulatory 1. May participate in regulatory inspections New Product Introductions & Process or Equipment Modifications 1. Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications. 2. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects. Change Control 1. Assist manufacturing change owner on CCRB packages impacting the process. Projects and Initiatives 1. Participate on the assessment or implementation of special projects or initiatives. Other functions may be assigned. EDUCATION/LICENSES - Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience or Associate’s degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience. COMPETENCIES/SKILLS - Detailed technical understanding of bioprocessing unit operations. - Skilled in performance of GMP production operations. - Regulatory knowledge and interactions. - Participate and help lead cross-functional teams. - Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality. - Organizational, technical writing and presentation skills. - Basic project management skills. - Basic knowledge of control charting. 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. Powered by JazzHR