CQV Validation Engineer I — Hybrid Career in Life Sciences

Genesis AEC, Inc.; Orange (CA); Hybrid; USD 60,000 - 70,000; Full time

Benefits offered by this job

Comprehensive medical/dental/vision

Flexible scheduling

Competitive 401k match

Job summary

Genesis AEC, Inc. is seeking a Validation Engineer I to join its CQV team in California. The role supports commissioning, qualification, and validation activities across packaging, automation, filling, molding, control, and robotic systems.

The engineer will write IQ/OQ/PQ protocols, conduct field inspections, and participate in FAT/SAT/testing while reviewing submittals and startup reports. Hybrid work is allowed with client/site demands.

Qualifications

• Associate's and/or Bachelor's degree in Science or Engineering.
• 0–2 years of previous experience, internship experience can be included.
• Strong computer skills, proficient with MS Office applications.
• Strong oral and written communication skills.
• Hybrid working arrangements are permitted with management approval; however, client and project demands may require up to 5 days a week onsite.
• Able to commute to multiple job sites during the workweek.
• Overnight travel will be required when supporting out-of-town projects (most projects are within 50 miles of the Genesis office).

Responsibilities

• Support creation and execution of CQV documentation (IQ/OQ/PQ) for equipment, facility systems, and utilities.
• Perform field inspections of equipment and utility systems.
• Walk-down design and vendor drawings in the field.
• Witness or participate in FAT, SAT, and Functional Testing.
• Review vendor and contractor submittals, startup reports, and documentation.
• Read and understand technical documents.
• Develop validation specifications (URS, FRS).
• Develop risk assessments and traceability matrices.
• Develop CQV project and validation plans.

Skills

Oral and written communication

Hybrid work adaptability

Self-motivation

Education

Associate's or Bachelor's degree in Science or Engineering

Tools

MS Office

Job description

Genesis AEC, Inc. is seeking a Validation Engineer I to join its CQV team in California. The role supports commissioning, qualification, and validation activities across packaging, automation, filling, molding, control, and robotic systems.

The engineer will write IQ/OQ/PQ protocols, conduct field inspections, and participate in FAT/SAT/testing while reviewing submittals and startup reports. Hybrid work is allowed with client/site demands.