Validation Specialist
Validation Specialist
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Job Description
For Project Validation servicesin the Engineering & Manufacturing areas.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degree in Engineering or Scienceand at least five(5 years of exposure to Validationactivitieswithin the Pharmaceutical or Medical Devices industry.
- Exposure in Packaging Validations Design Control and Product/Process Transfer preferred.
- Bilingual (Spanishand English)
- Shift: Administrative& according to business needs
- Experience in:
- European Union Medical Device Regulation (EU MDR 2017/745 European Union Medical Device Directive 2007/47/EC and ISO13485:2016 Medical Devices Quality Management Systems.
- Change Controls Validation Plans Validation Protocols Technical/investigation reports SOP etc.
- 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)
- Data Gathering Participate in the discovery and compilation of required documentation to be evaluated.
- Gap Assessments Assess of all manufacturing documentation such as product device master record (drawings specifications bill of materials production router/instructions procedures labeling) process flow charts incoming inspections inprocess inspections final inspections validation plans and process validations among others.
- Remediation Plan Perform tasks identified as part of the remediation plan including but not limited to: validation documentation generation and (change control validation plans validation protocols validation closure reports technical reports / memos) and manufacturing documentation update through site change orders 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 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
Employment Type
Contract
