C&Q Lead
Flexible & Integrated Technical Services, LLC
Gurabo, PR
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JOB DETAILS
SKILLS
Automation, Biology, Biotech and Pharmaceutical, Calendar Management, Change Control, Commissioning, Construction Engineering, Current Good Manufacturing Practice (cGMP), Customer Support/Service, Data Quality, Detail Oriented, Documentation, English Language, Manufacturing, Medical Equipment, Multilingual, Plan Meetings, Project Schedule, Regulations, Resource Leveling, Schedule Development, Spanish Language, Startup, Testing, Vendor/Supplier Management
LOCATION
Gurabo, PR
POSTED
2 days ago
For Validation and Commissioning & Qualification support in the Engineering area.
WHAT MAKES YOU A FIT: 
The Technical Part:
- Bachelor’s Degree in Life Science or Engineering, and previous years of exposure in Validation Life Cycle 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:
- Process Commissioning and Qualification.
- Validation coordination activities.
- 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!
- Development of an overall CQ plan in conjunction with the Client project scheduler.Meeting and delivering key project milestones.
- Lead various weekly multidisciplinary CQV, Eng, CM and USER coordination meetings. Org chart maintenance and resourcing.
- HSE and Safe Start-Up including LOTO. CQV Doc Preparation. CQV Execution Readiness. CQV Execution. P+ID Walk down and Punch item Categorization.
- Deviation Management & Change Control (Process and Automation). Punch List Management Vendor Management.
- Developing and Reviewing CQ test plans and specifications prior to their approvals.
- Development and maintenance of training material, matrix and files for all those involved in CQV activities (Integrator, CSV provider, Vendors, Client USERs).
- Management and Filing of CQV related documentation.
- Management: Compliance with a schedule at a system and area level with the planned resource levels.
- 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!
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About the Company
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