Senior CQV Validation Specialist, CIP/SIP for Biotech

Veg Group; United States; On-site; Full time

Benefits offered by this job

Empowering work environment

Opportunity for professional development

Supportive team culture

Job summary

A leading validation services provider in the United States is seeking a Validation Specialist to oversee Commissioning, Qualification, and Validation activities related to Cleaning-In-Place systems in biotech. The role requires a bachelor's degree in engineering and 7-10 years of CQV experience in pharmaceutical environments. Responsibilities include executing protocols, generating documentation, and ensuring compliance with industry standards. Strong skills in cleaning validation and proficiency in both English and Spanish are essential. This position offers an opportunity to make substantial contributions within a supportive team.

Qualifications

• 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.
• Strong knowledge of cleaning validation and sterilization principles.
• Expertise in ASTM E2500, ISPE Baseline Guides, and FDA/EMA guidelines.

Responsibilities

• Plan, coordinate, and execute all CQV activities related to CIP and SIP systems.
• Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.
• Generate and review documentation in compliance with ASTM E2500 and GAMP 5.

Skills

Cleaning validation

Sterilization principles

Automation integration

Technical documentation

Bilingual (English/Spanish)

Education

Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering

Tools

DeltaV

SCADA

PLC systems

Kneat

ValGenesis

Job description

A leading validation services provider in the United States is seeking a Validation Specialist to oversee Commissioning, Qualification, and Validation activities related to Cleaning-In-Place systems in biotech. The role requires a bachelor's degree in engineering and 7-10 years of CQV experience in pharmaceutical environments. Responsibilities include executing protocols, generating documentation, and ensuring compliance with industry standards. Strong skills in cleaning validation and proficiency in both English and Spanish are essential. This position offers an opportunity to make substantial contributions within a supportive team.