Project Manager
Flexible & Integrated Technical Services, LLC
For Project Manager services in the Manufacturing Engineering areas.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor's Degree in Engineering and a minimum of seven (7) years of experience in Project Management activities within the Pharmaceutical or Medical Devices industry.
- Bilingual: Spanish and English
- Shift: Administrative & according to business needs
- Experience in:
- Developing and executing comprehensive project plans, including objectives, deliverables, schedules (using Gantt charts in MS Project), risk assessments, and resource allocation.
- Validation Life Cycle
- Activities coordination
- Regulatory requirements (e.g., FDA, ISO)
The Personality Part:
- Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Project Planning: Develop a comprehensive project plan that outlines objectives, deliverables, timelines, and resource allocation. Conduct risk assessments to identify potential challenges and develop mitigation strategies.
- Budget Management: Prepare and manage the project budget, ensuring accurate tracking of expenses versus planned costs. Implement cost-control measures to stay within financial targets.
- Team Leadership: Assemble and lead a cross-functional team, including design, engineering, regulatory, quality assurance, and marketing professionals. Facilitate effective communication and collaboration among team members.
- Stakeholder Engagement: Identify and manage key stakeholders, including internal teams, external partners, regulatory bodies, and customers. Keep stakeholders informed about project progress, challenges, and changes.
- Regulatory Compliance: Ensure that the project adheres to relevant regulatory requirements and industry standards (e.g., FDA regulations, ISO standards). Coordinate with regulatory affairs teams to prepare submissions and maintain compliance throughout the project lifecycle.
- Quality Assurance: Implement and oversee quality assurance processes to ensure the medical device meets all specifications and safety standards. Address any quality issues that arise during the project.
- Schedule Management: Create and maintain a detailed project schedule that tracks milestones, deadlines, and deliverables. Coordinate activities and manage dependencies to minimize delays.
- Change Management: Manage project scope and changes by evaluating requests and assessing their impact on timelines and budgets. Ensure proper documentation and approval processes are followed for any changes.
- Communication: Provide regular updates to executive management and stakeholders regarding project status and key performance indicators. Facilitate meetings, workshops, and presentations to communicate project developments.
- Problem Solving: Identify and address project-related issues promptly, employing problem-solving techniques to overcome obstacles. Foster an environment where team members feel comfortable raising concerns and proposing solutions.
- Project Closure: Ensure proper project closure by conducting final evaluations, documenting lessons learned, and obtaining necessary approvals. Review project outcomes against initial objectives and provide reports to stakeholders.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the next piece?
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