Senior Validation Engineer - Biopharma GMP Specialist

KBI Biopharma, Inc.; Boulder (CO); On-site; USD 84,000 - 105,000; Full time

Benefits offered by this job

Annual bonus

Medical/dental/vision coverage

PTO and holidays

401K matching with vesting in 60 days

Employee recognition programs

Total rewards strategy

Job summary

KBI Biopharma, Inc. is seeking a Level II Validation professional to facilitate the validation lifecycle across multiple disciplines in a multi-product facility. You will coordinate validation testing, contribute to change control, and support business efficiency projects.

The role requires a Bachelor’s in a scientific/biochemical engineering field with 5+ years in fermentation/cell culture environments, plus strong Quality Systems and cGMP knowledge.

Qualifications

• Bachelor’s degree in a scientific or biochemical engineering discipline with 5+ years’ experience in fermentation/cell culture.
• Knowledge of Quality Systems and cGMP requirements across regulatory jurisdictions (FDA, EU, ICH).
• Strong interface skills across quality, engineering and technical disciplines.
• Demonstrated integrity, accountability, and customer service focus.

Responsibilities

• Support drafting, execution, and review/approval of validation documentation, deviations, CAPAs, and change controls
• Conform to all Quality System and cGMP requirements for documentation and data integrity
• Support risk and impact assessments pertaining to engineering and pre-requisite validation work processes
• Assist with inspection preparation, project coordination and other Validation tasks
• Support and/or lead improvements and departmental initiatives

Skills

Quality Systems

cGMP knowledge

Project management

Risk management

Documentation

Cross-functional collaboration

Analytical thinking

Education

Bachelor’s degree in scientific or biochemical engineering

Master’s degree (preferred)

Tools

MS Office suite

Electronic Document/Info Management Systems

Engineering software tools

MS Excel

Job description

KBI Biopharma, Inc. is seeking a Level II Validation professional to facilitate the validation lifecycle across multiple disciplines in a multi-product facility. You will coordinate validation testing, contribute to change control, and support business efficiency projects.

The role requires a Bachelor’s in a scientific/biochemical engineering field with 5+ years in fermentation/cell culture environments, plus strong Quality Systems and cGMP knowledge.