For Cleaning Validation services in the Engineering & Manufacturing areas.
WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering and three to five (3-5) years of exposure in Equipment Cleaning Validation activities within the Pharmaceutical or Medical Devices industry. Bilingual (Spanish and English) Shift: Administrative & according to business needs Experience in: Cleaning Validation Validations such as: manufacturing equipment, laboratory equipment, cleaning, test method, computer systems, packaging, shipping, shelf life (aging), sterilization, facilities, clean rooms, and utilities (HVAC, Compressed Air, Water Systems) FDA, OSHA, EPA, ISO, 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 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) Plans, develops, and implements documentation, procedures, and trainings necessary for the manufacturing process engineering team.
Generation and execution of validation plans, validation protocols (FAT/SAT/IQ/OQ/PQ/CSV's), 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 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) freeze drying, CCA, DIUF, RO/DI, WFI, Pure Steam, SIP Systems, HEPA Filters, controlled temperature units, and laboratory equipment.
Evaluate, investigate and document non-conformances incidents and/or protocol deviations.
Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
Oversee validation contractor resources.
Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.
Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.
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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