Project Validation Specialist

For Project Validation services in the Engineering & Manufacturing areas.

WHAT MAKES YOU A FIT :   The Technical Part : Bachelor’s Degree in Engineering or Science and at least five (5) years of exposure to Validation Engineering activities within the Pharmaceutical or Medical Devices industry.

, Bilingual (Spanish and 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 utilities (HVAC, Compressed Air, Water Systems) required.

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, develop, and implement documentation, procedures, and training necessary for the engineering team, production and quality personnel.

Generation and execution of change controls, validation plans, validation protocols (FAT / SAT / IQ / OQ / PQ / CSV’s), and completion reports.

Provide statistical analysis of the date to support the 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) Packaging Equipment (e.g.

Multivac Machine), freeze-drying, CCA, DIUF, RO / DI, WFI, Pure Steam, SIP Systems, HEPA Filters, chillers, controlled temperature units, and laboratory equipment.

Evaluate, investigate and document non-conformances incidents and / or protocol deviations.

Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.

Work on project teams with other internal departments, external vendors, and customers as required.

Assure that existing processes and assigned activities fully comply with regulatory and / or international agencies, such as FDA, ISO, OSHA, EPA, among others.

Performs other related duties as necessary.

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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