C&Q Lead

FITS LLC; Northern (KY); Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Excellent customer service

Job summary

FITS LLC in Kentucky is seeking Validation, Commissioning & Qualification support in the Engineering area. The role requires a Bachelor's in Life Science or Engineering and experience in Validation Life Cycle within the pharmaceutical industry, plus bilingual Spanish and English.

As a CQV specialist, you will develop CQ plans, lead cross-functional CQV/Eng/CM/USER meetings, manage deviations changes, and ensure documentation quality in line with cGMP and Data Integrity guidelines.

Qualifications

• Must have a Bachelor’s degree in Life Science or Engineering and experience in Validation Life Cycle in the pharmaceutical industry.
• Bilingual Spanish and English written and spoken.
• Administrative shift, flexible to business needs.
• Strong skills in writing documentation in English and using MS Office.
• Experience in Process Commissioning and Qualification and Validation coordination activities.
• Familiarity with Change Control development, cGMPs and Data Integrity.

Responsibilities

• Develop an overall CQ plan in collaboration with the Client project scheduler and meet key milestones.
• Lead weekly multidisciplinary CQV/Eng/CM/USER coordination meetings; manage organization and resources.
• HSE and Safe Start-Up activities including LOTO; CQV documentation preparation and execution readiness.
• Develop and review CQ test plans and specifications prior to approvals.
• Create and maintain training materials and files for CQV teams and stakeholders.
• Manage CQV documentation filing and ensure schedule compliance at system/area level.

Skills

Bachelor's Degree in Life Science or 4

Bilingual (Spanish & English)

MS Office (Excel, Word, PPT)

Validation Life Cycle experience

Process Commissioning andQualification

Validation coordination activities

Change Control Development

cGMP & Data Integrity knowledge

Education

Bachelor's Degree in Life Science or Engineering

Tools

MS Office

Job description

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, 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?