Manufacturing Engineer

hace 4 semanas

Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

For Project Validation services in the Engineering & Manufacturing areas.
WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's Degree in Engineering or Science and at least four (4) years of exposure to Manufacturing activities within the Pharmaceutical or Medical Devices industry.  Ability to lead teams through complex projects and provide departmental technical leadership.
Bilingual (Spanish and English) Shift: Administrative & according to business needs  Experience in: Validations such as manufacturing equipment, manufacturing processes, stability, or aging, are required.
Technical documentation such as Change Controls, Validation Plans, Validation Protocols, Technical/investigation reports, SOP, and others.
GMP & GDP regulations 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) Participate on cross-functional project teams including R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and manufacturing to maintain and improve surgical products.
Responsible for reviewing and updating applicable product specifications and drawings for legacy products.
Responsible for identifying acceptance criteria for product specifications.
Develop project plans for qualifications and ensure team resources identified, team members help accountable to deliverables, and milestones met.
Provide engineering knowledge and resolve design, manufacturing, and quality-related problems impacting existing products.
Develop and issue change control documentation to address changes in components and/or raw materials requested by the suppliers following applicable procedures.
Ability to adjust priorities when with shifting business needs.
Support manufacturing process improvements for CSS products in both internal manufacturing facilities and in partnership with external suppliers.
Provide project leadership to improve existing products and associated manufacturing processes.
Support the selection and validation of replacement materials, such as polymers, metals, and adhesives, for CSS applications.
Support corrective actions and the implementation of all corrective actions to ensure improvements are attained.
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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