CQV & Validation Lead — Orchestrate Pharma Commissioning

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

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.