Validation Engineer II – Pharmaceuticals
Denver Metropolitan | full-time | onsite | $90,000 – $100,000

Intro
An established sterile injectable pharmaceutical manufacturer is seeking a Validation Engineer II. This role independently plans, executes, and documents validation activities across equipment, facilities, utilities, cleaning, and process validation, ensuring compliance with cGMP, FDA, EU, and other regulatory requirements.

Responsibilities

• Plan and coordinate validation activities for cross-functional projects, including validation plans, protocols, and reports.
• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities, and processes, including leading cleaning and sterilization validation (autoclaves, SIP systems).
• Conduct risk assessments (e.g., FMEA), analyze validation data, and prepare audit-ready reports in collaboration with QA, Manufacturing, Engineering, and Quality Control.

Qualifications and Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field required
• 2+ years of validation experience, preferably in a sterile pharmaceutical or biotech environment
• Strong understanding of cGMP, FDA, and EU regulatory requirements; familiarity with aseptic processing and cleanroom classifications preferred

For more information please contact Clara Pollard at [email protected]