C&Q Sr. Consultant

FITS LLC; Wilson (NC); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

FITS LLC in the United States seeks a Validation and Commissioning & Qualification support specialist in Engineering. The role focuses on CQV plan development, coordinating cross-functional teams, and ensuring CQV readiness and documentation.

The ideal candidate will have a life science or engineering degree, pharma validation exposure, and bilingual Spanish/English communication. Administrative shift and MS Office proficiency are required.

Qualifications

• Bachelor's degree in Life Science or Engineering.
• Exposure to Validation Life Cycle in pharma.
• Bilingual Spanish and English preferred.

Responsabilités

• Develop CQV plans with the client project scheduler and meet milestones.
• Lead weekly CQV/Eng/CM/USER coordination meetings; manage org chart.
• Ensure HSE and startup activities including LOTO and CQV readiness.
• Oversee deviation management, change control, and vendor management.
• Create and review CQ test plans and specs for approvals.
• Develop training materials and maintain CQV documentation.
• Manage scheduling and resource levels at system and area level.

Connaissances

CQV Experience

Validation Life Cycle

Bilingual (Spanish & English)

MS Office

Formation

Bachelor’s Degree in Life Science or Engineering

Outils

MS Office

Description du poste

For Validation and Commissioning &Qualification support in the Engineering area.

WHAT MAKES YOU A FIT:

• Bachelor’s Degree in Life Science or Engineering, andpreviousyears 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.
• cGMPsand Data Integrity regulations and guidelines.

The Personality Part:

• 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!

AS A PIECE OF FITS, YOU WILL:

(The day-to-day on the job)

• 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.

BEING A FITS PIECE COMES WITH PERKS:

• 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!

WHO WE ARE:

We are a Service Provider companydifferent 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 industryclients with top-notch quality talent.We're FITS!

Are you the Next Piece?