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, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
1.Project Planning and Coordination
Develop a detailed project timeline in collaboration with the business unit.
Establish project milestones and deliverables.
Coordinate with internal stakeholders and external contractors to ensure alignment on project objective
2. Scope of Work and Documentation
Develop comprehensive Scope of Work (SOW) documents for each project component.
Create User Requirements Specifications (URS) for all equipment and systems.
Ensure all documentation meets regulatory and industry standards.
3. Contractor Management
Identify, evaluate, and select contractors for various project components.
Manage contractor execution, ensuring adherence to project timelines, quality standards, and safety protocols.
Conduct regular site inspections to monitor progress and compliance.
4. Budget Management
Oversee the project budget of approximately $15 million.
Track expenditures and manage financial resources to ensure cost-effectiveness.
Provide regular budget updates and forecasts to stakeholders.
5. Reporting and Communication
Prepare and deliver daily, weekly, and monthly reports to local management, corporate offices, and customers as required.
Facilitate regular project meetings and provide status updates.
Address any issues or concerns promptly and effectively.
6. Quality Assurance and Compliance
Ensure all project activities comply with Good Manufacturing Practices (GMP) and other relevant regulations.
Implement quality control measures to ensure high standards of workmanship.
Conduct final inspections and obtain necessary approvals and certifications.
Specific Project Components
1.
F
ull Roof Remediation
Assess current roof conditions and develop a remediation plan.
Oversee roof repair or replacement activities.
Ensure compliance with safety and environmental regulations.
2. Air Handling Units Replacement (3 to 4 Units)
Evaluate existing air handling units and determine replacement needs.
Coordinate the procurement and installation of new units.
Ensure minimal disruption to ongoing operations.
3. Chilled Water Optimization Project
Analyze current chilled water systems and identify optimization opportunities.
Implement changes to improve efficiency and performance.
Monitor system performance post-implementation.
4. Fit and Finish Projects in GMP Rooms
Plan and execute fit and finish improvements in GMP rooms.
Ensure all work meets GMP standards and regulatory requirements.
Coordinate with production teams to minimize impact on operations.
5. Dust Control Improvement Projects
Identify areas requiring dust control improvements.
Implement effective dust control measures.
Monitor and evaluate the effectiveness of implemented solutions.
6. Steam and Condensate, Drains, Insulation Upgrades
Assess existing steam and condensate systems, drains, and insulation.
Develop and execute upgrade plans.
Ensure all upgrades meet safety and performance
Qualifications and Skills
Bachelor's degree in Construction Management, Engineering, or a related field.
Minimum of 10 years of experience in construction project management, preferably in the pharmaceutical or manufacturing industry.
Proven track record of managing large-scale projects with budgets exceeding $10 million.
Strong knowledge of GMP regulations and industry standards.
Excellent leadership, communication, and organizational skills.
Proficiency in project management software and tools
Deliverables
Detailed project timeline and milestones.
Comprehensive SOW and URS documents.
Regular progress and budget reports.
Final project documentation and compliance certifications.
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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