For Process Development and Validation and manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor Degree in Engineering and five5years of experience in the regulated industry.
- Bilingual (English and Spanish).
- Administrativeand according to business needs.
- Ability to identify areas of improvement in processes and develop strategies to optimize the efficiency quality and/or yield of those processes that are being developed.
- Experience in:
- Process and/or equipment validation activities (IQ OQ PQ).
- Responsible for reviewing and developing process validation protocols and reports.
- Functional areas during the validation activities.
The Personality Part:
- If you feel a passion for transforming lives and innovating with new medical solutions using global collaboration high performance diversity and winning spirit then this is a job for you.
AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)
- Support process and/or equipment validation activities (IQ OQ PQ); process performance qualification activities and develop Master validation plans for new processes or products.
- Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.
- Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans and other development procedures.
- Design and develop in-process and receiving quality systems for new processes and components
- Generate equipment documentation such as equipment entries evaluations PM and calibration procedures as required.
- Define gages tools and equipment for the test methods developed.
- Generate manufacturing instructions for new processes being developed
- Work cross-functionally with other departments to accomplish PD tasks.
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 family-oriented and focused on our resources well-being while providing our Pharmaceutical Medical Device and Manufacturing industryclients with top-notch quality talent.Were FITS!
Are you the next piece
Required Experience:
Senior IC