Validation Engineer Process Development
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
For Process Development and Validation services in the manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor Degree in Engineering and three (3)years of experience in the medical devices industry.
- Bilingual: English and Spanish
- Skills: Writing Skills
- Shift: Administrative and according to business needs.
- Experience in:
- Process and/or equipment validation activities (IQ OQ PQ).
- Responsible for reviewing and developing process validation protocols and reports.
- Automation systems testing.
- Process Development and/or Manufacturing Process Engineering.
The Personality Part:
Our Next Piece is someone who treats everyone they meet like family especially our resources clients and team other words being a customer service pro is one ofyour (many) talents. Being the Piece means youre 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)
- 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 with 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.
- Assures that appropriate resources (personnel tools etc.) are maintained to assure Quality System compliance and adherence to the Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
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
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
