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Sr. Parenteral Inspection Technology Specialist

Company:
fitspr.com
Location:
Maguayo, Puerto Rico, 00646
Posted:
April 17, 2024
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Description:

For Inspection services in the Engineering area

WHAT MAKES YOU A FIT:

The Technical Part:

Bachelor’s degree in Science or Engineering (Mechanical, Electrical or Computer) & five (5) years of exposure in the Pharmaceutical industry.

Fully bilingual (Spanish and English)

Project Management Skills

Experience in:

Parenteral Inspection and Packaging processes

Technical Writing (protocols, assessments, CAPAs, etc.)

Inspection/Packaging Technology experience (plus)

Project Management.

cGMP's, OSHA and FDA Regulations.

The Personality Part:

If you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

Improve inspection processes, technologies, and systems to ensure compliance with drug quality and cost specifications.

Write test procedures, inspection machinery specifications, performs line trials and troubleshooting, work with inspection technology machinery vendors, etc.

Coordinate inspection process validation and line trial activities with local validation, production, engineering, planning and quality groups as needed.

Support new inspection technology and product transfers.

Ensure that equipment can handle all current products configuration components and will determine whether it can support proposed changes.

Justify, design, specify, purchase, test, install and validate any new equipment purchases.

Manage project timetables for new and ongoing projects.

Provide project status using project plans, presentations, or written reports.

Provide assistance and technical support to inspection projects for products manufactured at the pharmaceutical manufacturing site.

Oversight and support the overall inspection certification program, personnel certification, new inspection methodology, inspection test set maintenance and control.

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?

Apply