C&Q Lead

FITS LLC; Philadelphia (Philadelphia County); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS LLC in Philadelphia is seeking Validation and Commissioning & Qualification support in the Engineering area. The candidate will contribute to CQV activities across the project lifecycle, coordinating commissioning tests and documentation to ensure quality and compliance.

The role requires a Bachelor’s degree in Life Science or Engineering, with exposure to the Validation Life Cycle in the pharmaceutical industry.

Qualifications

• Bachelor’s degree in Life Science or Engineering with exposure to the Validation Life Cycle.
• Experience in Process Commissioning and Qualification.
• Validation coordination activities and Change Control Development.
• cGMPs and Data Integrity regulations and guidelines.
• Good skills in writing general documentation in English and using MS Office applications.
• Bilingual Spanish and English.

Responsibilities

• Develop an overall CQV plan in alignment with the Client project scheduler and deliver key milestones.
• Lead weekly multidisciplinary CQV, Eng, CM and USER coordination meetings with org chart maintenance and resource planning.
• CQV documentation: preparation, execution readiness, execution, P&ID walkdowns, punch item categorization.
• Manage deviations and changes (Process and Automation); oversee vendor and punch list activities.
• Develop and review CQ test plans and specifications for approvals.
• Create and maintain training materials and files for CQV team members and clients.
• Ensure QA/compliance with schedules at system and area levels.

Skills

Process commissioning

Validation coordination

Change control

GMP compliance

MS Office proficiency

Documentation in English

Bilingual Spanish/English

Education

Bachelor’s degree in Life Science or Engineering

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.
• 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.

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?