Facilities Validation Engineer
Facilities Validation Engineer
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Job Description
For Project Validation servicesin the Facilities areas.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degree in Engineering or Scienceand at leastsix (6) years of exposure to Validation Engineering activitieswithin the Pharmaceutical or Medical Devices industry.
- Strong project management skills with experience leading complex cross-functional initiatives
- Bilingual (Spanishand English)
- Shift: Administrative& according to business needs
- Experience in:
- Facilities & Utilities Validation
- FDA OSHA EPA GMPs ISO standards and GAMP 5; strong understanding of Computer Systems Validation Life Cycle and regulatory guidelines.
- Generating validation documentation including URS FRS SDS traceability matrices and IQ/OQ/PQ protocols.
- Organizational Excellence Lean and Six Sigma methodologies.
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 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)
- Plans develops and implements documentation procedures and training necessary for the engineering team.
- Actively participate in the Validation Life Cycle of regulated projects by reviewing validation documentation participating in application requirements definition risk assessments traceability matrix validation protocol development validation testing and deviation management.
- Generation of validation plans User Requirement Specifications (URS) Functional Requirement Specifications (FRS) System Design Specifications (SDS) traceability matrix as well as development and execution of validation protocols (FAT/SAT/IQ/OQ/PQ) and completion reports.
- Develop statistically based sampling plans for in-process and final testing and inspections and validations.
- Review and approve validations and completion reports for new and existing computer and automation systems.
- Evaluate investigate and document non-conformances incidents and/or protocol deviations.
- Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
- Manages and supervises the installation of equipment and controls/software modifications for automated equipment.
- Lead process improvement projects to improve the validation of computerized systems.
- 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 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
Employment Type
Contract
