Senior Validation Engineer: CQV Leader for GMP Projects

CAI; St. Louis (MO); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Comprehensive Health Insurance

Paid Time Off

Life Insurance

Long Term Disability

Job summary

CAI in the United States is seeking a CQV Engineer with 3+ years in Pharmaceutical/Life Sciences to perform commissioning, qualification and validation activities with a strong focus on safety.

You will support CQV documentation, planning, testing, and vendor coordination, traveling across the U.S. and potentially internationally. A BS/BA in Engineering, Chemistry, or Life Sciences and GMP experience are required.

Qualifications

• Bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute for education)
• 3+ years of related experience in the Pharmaceutical/Life Sciences industry
• Essential experience in a GMP (Good Manufacturing Practice) environment
• Outstanding oral and written communication skills
• Strong problem-solving abilities
• Customer-focused mindset
• Willingness and flexibility to travel throughout the U.S. and potentially internationally

Responsibilities

• Perform CQV activities with a strong focus on safety
• Deliver C&Q activities in alignment with project schedules
• Track and report progress of CQV efforts
• Support the generation and review of CQV procedures for client projects
• Review and revise qualification-related documents, including SOPs, master plans, and execution plans
• Assist with CQV review and qualification of equipment design
• Support planning of commissioning spares and consumables
• Allocate project resources for efficient execution
• Coordinate support and logistics during CQV execution
• Support execution of design reviews, equipment shakedown, commissioning, FATs, IQ, OQ, and PQ activities
• Coordinate with project contractors and equipment vendors to execute required testing

Skills

Strong communication

Problem-solving abilities

Customer-focused mindset

Willingness to travel

Education

Bachelor’s degree in Engineering, Chemistry, or Life Sciences

Job description

CAI in the United States is seeking a CQV Engineer with 3+ years in Pharmaceutical/Life Sciences to perform commissioning, qualification and validation activities with a strong focus on safety.

You will support CQV documentation, planning, testing, and vendor coordination, traveling across the U.S. and potentially internationally. A BS/BA in Engineering, Chemistry, or Life Sciences and GMP experience are required.