Project Validation Specialist
Project 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 leastfive 5 years of exposure to Validation Engineering activitieswithin the Pharmaceutical or Medical Devices industry.
- Bilingual (Spanishand English)
- Shift: Administrative& according to business needs
- Experience in:
- Validations such as: packaging equipment manufacturing equipment laboratory equipment cleaning test method computer systems shipping shelf life (aging) sterilization facilities clean rooms and utilitiesrequired.
- Operational Excellence and Lean Six Sigma
- 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)
- Plans develops and implements documentation procedures and training necessary for the engineering team production and quality personnel.
- Generation and of change controls validation plans validation protocols (FAT/SAT/IQ/OQ/PQ/CSVs) and completion reports.
- Provide statistical analysis of the data to support the reports.
- Develop statistically based sampling plans for inprocess and final testing and inspectionsand validations.
- Review and approve validations and completion reports for new and existing products processes and equipment.
- Troubleshooting equipment/processes that do not perform as intended during validation runs.
- Recommend process/quality improvements as part of validation runs.
- Work with new and existing equipment processes utilities facilities and cleaning validations to include (but not limited to) Packaging Equipment (e.g. Multivac Machine) freezedrying CCA DIUF RO/DI WFI Pure Steam SIP Systems HEPA Filters chillers controlled temperature units and laboratory equipment.
- Evaluate investigate and document nonconformance incidents and/or protocol deviations.
- Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies such as FDA ISO OSHA EPA among others.
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
