For Project Validation servicesin the Engineering & Manufacturing areas.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degree in Engineering or Scienceand at least four(4 years of exposure to Manufacturing activitieswithin the Pharmaceutical or Medical Devices industry.
- Ability to lead teams through complex projects and provide departmental technical leadership.
- Bilingual (Spanishand English)
- Shift: Administrative& according to business needs
- Experience in:
- Validations such asmanufacturing equipment manufacturing processes stability or aging are required.
- Technical documentation such asChange 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 youre full of bright ideas and eager to innovate always bringing topquality results to the table. Are you ready to take on this new challenge
AS A PIECE OF FITS YOU WILL: (The daytoday on the job)
- Participate on crossfunctional 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 qualityrelated 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 companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys 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 familyoriented and focused on our resources wellbeing while providing our Pharmaceutical Medical Device and Manufacturing industryclients with topnotch quality talent.Were FITS!
Are you the Next Piece
Required Experience:
Senior IC