For Validation services in the Manufacturing/Automation area.
WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering and at least seven years of exposure in Automation activities within the Pharmaceutical or Medical Devices industry. Bilingual (Spanish and English) Shift: Administrative & according to business needs Experience in: FDA regulated industry Computer system validation (CSV), data integrity, qualification of automated manufacturing, testing, vision inspection systems, and packaging equipment.
Automated PC/HMI/PLC based case packaging manufacturing system, and related packaging/serialization equipment on highly automated syringes packaging line.
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 you're 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) Develops validation documentation for a fully automated steam sterilization trace and track system.
Reviews validation documentation, and participates in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing, and deviation management.
Generates validation plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), and traceability matrix, as well as development and execution of validation protocols (FAT/SAT/IQ/OQ/PQ), and completion reports.
Develops statistically based sampling plans for in-process and final testing and inspections, and validations.
Reviews and approves validations and completion reports for new and existing computer and automation systems.
Troubleshoot computer and automation systems that do not perform as intended during validation runs.
Recommends process/quality improvements as part of validation runs.
Analyze the results of testing and determine the acceptability of results against predetermined criteria.
Evaluate, investigate, and document non-conformance incidents and/or protocol deviations.
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.
Assures 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 company different from the rest.
We pride ourselves in how we treat the most important piece of our company's 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 industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?
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