Flexible & Integrated Technical Services, LLC
Sr. Manufacturing Engineer
Medical Device - Caguas, Puerto Rico - Contracted
For Manufacturing services in the Engineering area.
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The Technical Part:
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?
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s degree in Engineering & three (3) years of relevant experience within the Medical Devices or Pharmaceutical industry.
- Bilingual (Spanish & English).
- Shift: Administrative, and according to business needs.
- Experience in:
- Validation Execution (IQ, OQ, PQ), and Report Documentation.
- Manufacturing processes and equipment troubleshooting.
- Quality Systems (CAPA, Deviations, and Investigations).
- 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 of 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?
- Applies highly developed specialist knowledge and skills in project management, project planning, budgets and methodologies.
- Manages the most important and challenging projects.
- Defines project resources, performance reviews and post implementation evaluations.
- Takes ownership of the successful implementation of the projects.
- Ability to execute highly complex or specialized projects.
- Lead complex technical projects with multiple inter-coordinating elements where problem resolution may involve the application of new methods and/or approaches and may require consideration of impact with other system components and/or users.
- Lead and/or participate on cross-functional teams to support NPI methodology.
- Responsible for completing documentation in a timely manner and in accordance with business standards.
- Runs studies and qualification/validations on the line as needed. Writes protocols and reports with no oversight.
- Determines overall validation strategy including validation type/requirements, determination of process outputs, sampling plans and performs data analysis.
- Provides guidance for validation deviations and complex validation data analysis.
- Leads root cause analysis efforts for high complexity manufacturing events, utilizing DMAIC model and A3s.
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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