CQV Lead: Validation & Commissioning Expert

Flexible & Integrated Technical Services, LLC; Philadelphia (Philadelphia County); Vor Ort; USD 65.000 - 95.000; Vollzeit

Zusammenfassung

Flexible & Integrated Technical Services, LLC is seeking a professional to support Validation, Commissioning and Qualification activities in our Engineering team in the United States. You will contribute to CQV planning, meetings and documentation, coordinating with project teams across the pharmaceutical lifecycle.

The position requires a Life Science or Engineering degree, hands-on CQV exposure, bilingual Spanish and English, and strong English writing skills with MS Office.

Qualifikationen

• Bachelor’s degree in Life Science or Engineering required.
• Exposure to Validation Life Cycle in pharmaceutical industry.
• Bilingual Spanish & English.
• Strong writing skills in English and MS Office proficiency.
• Experience in Process Commissioning and Qualification; validation coordination; change control; cGMPs and data integrity.

Aufgaben

• Develop CQV plan in coordination with client project scheduler.
• Meet and deliver key project milestones.
• Lead weekly CQV/Eng/CM/USER coordination meetings; manage org chart and resources.
• Ensure HSE and Safe Start-Up including LOTO.
• Prepare CQV documents and readiness for execution.
• Execute CQV activities and documentation updates.
• Walkdowns (P&ID) and punch item categorization.
• Manage deviations and change control (process and automation).
• Punch list management and vendor coordination.
• Develop and review CQV test plans and specs for approvals.
• Create and maintain training materials and files for CQV teams.
• Manage CQV documentation and schedule compliance at system and area levels.

Kenntnisse

Bilingual (Spanish & English)

English documentation writing

Ausbildung

Bachelor’s Degree in Life Science or Engineering

Tools

MS Office

Jobbeschreibung

Flexible & Integrated Technical Services, LLC is seeking a professional to support Validation, Commissioning and Qualification activities in our Engineering team in the United States. You will contribute to CQV planning, meetings and documentation, coordinating with project teams across the pharmaceutical lifecycle.

The position requires a Life Science or Engineering degree, hands-on CQV exposure, bilingual Spanish and English, and strong English writing skills with MS Office.