C&Q Lead

fitspr; Pennsylvania; On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Exceptional customer service culture

Job summary

FITS is a service provider delivering Validation, Commissioning and Qualification support for the pharmaceutical industry in the US. The role focuses on CQV planning, coordination across engineering and QC teams, and ensuring regulatory compliance.

You will develop CQ plans, manage meetings, prepare test plans, and maintain documentation while coordinating with vendors and clients. The position emphasizes attention to detail, client service, and regulatory awareness in a dynamic environment.

Qualifications

• Bachelor's Degree in Life Science or Engineering with exposure to Validation Life Cycle in Pharmaceuticals.
• Fluent in English with ability to write general documentation.

Responsibilities

• Develop an overall CQ plan with the Client project scheduler and meet milestones.
• Lead weekly CQV/Eng/CM/USER coordination meetings and manage resources.
• Prepare CQV documentation, execute readiness, and perform P&ID walkdowns.
• Manage Deviation & Change Control (Process/Automation) and punch lists.
• Develop and review CQ test plans and vendor training materials.
• Maintain CQV documentation and ensure schedule compliance.
• Coordinate with Integrators, CSV providers, and Client USERS.

Skills

Bachelors degree in Life Science or BI

Bilingual Spanish/English

Documentation in English

MS Office proficiency

Process CQV/Validation experience

Validation coordination

Change control development

cGMP and Data Integrity

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!