C&Q Engineer
Manati, Puerto Rico
Contracted
Pharmaceutical
Entry Level
For Validation and Commissioning & Qualification support in the Engineering area.
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The Technical Part:
- Bachelor’s Degree in Engineering, and previous exposure in Validation Life Cycle and Packaging activities within the Pharmaceutical Industry.
- Bilingual (Spanish & English)
- Shift: Administrative, and according to business needs.
- Good skills in writing general documentation in English and using MS Office applications.
- Experience in:
- Validation coordination activities.
- Commissioning and Qualification (C&Q).
- Change Control Development.
- cGMPs and Data Integrity regulations and guidelines.
- Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail that nothing gets past you. If this sounds like you, and 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!
- Write, execute, and maintain the validation protocol on a timely basis.
- Ensure timely, thorough, and complete execution of all protocols, meeting FDA requirements.
- Ensure that all new and existing protocols are effectively integrated into manufacturing processes.
- Ensure that documentation is thorough, accurate, and entered into the quality system on a timely basis.
- Ensures complete and thorough investigation of all product failures, batch failures, and deviations associated with validation sampling and testing.
- Develops documentation of investigations and communicates findings to ensure the chance of recurrence is significantly minimized and resolution satisfies validation requirements.
- Protocol generation for packaging equipment qualification.
- IOQ protocol generation, Protocol executions, and Final reports.
- PQ protocol generation and execution with required reports.
- Management of change controls (generation, routing, execution, and closing).
- One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out!
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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