Validation Engineer
Validation Engineer
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Job Description
For Validation services in the Process Development department.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degree in Engineering and at least four(4) years of experience in the medicaldevices industry.
- Bilingual: Spanish and English
- Soft Skills: Writing skills
- Shift: Administrative and according to business
- Experience:
- Validation Life Cycle
- Lasers
- 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)
- Conduct process equipment installation/operational/performance qualification studies to test their functionality.
- Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters.
- Identify and evaluate equipment enhancements to support intended qualified operational ranges.
- Support the evaluation of Change Controls to establish qualification assessments and performance qualificationrequirements during process and/or equipment modifications.
- Support process capability and statistical analysis related to equipment performance.
- Support the periodic review of equipment/system qualifications studies.
- Generate & execute protocols: IQ OQ PQ.
- Generate and execute equipment/software validation protocols (IQ TMVTQF) Process Characterization and Process Validation based on equipment capabilities.
- Validation engineering support of process and/or equipment upgrades replacements and modifications inthemanufacturing environment.
- Develop organize analyze and present interpretations of results for operational issues or validation engineeringprojects of significant scope and complexity.
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:
Manager
Employment Type
Contract
