Validation Engineer II

Kindeva Drug Delivery • St. Louis, MO

1d • Onsite

About The Position

The Floater Validation Engineer II provides validation engineering support across two pharmaceutical aseptic manufacturing facilities and one inspection and packaging site. This role assists with equipment qualification, aseptic process validation, cleaning validation, computer systems validation, and inspection/packaging validation activities. The position delivers flexible, cross-site validation coverage while executing protocols, performing testing, and authoring validation documentation under the direction of the Validation Manager.

Requirements

• Bachelor’s degree in Engineering, Chemistry, Biochemistry, Microbiology, Pharmacy or related discipline
• 5+ years of relevant validation or pharmaceutical manufacturing experience, or equivalent combination of education and experience.
• Knowledge of cGMP and regulatory guidance.
• Experience in aseptic manufacturing and inspection/packaging operations.
• Ability to interpret technical documentation and identify deviations.
• Proficiency with Microsoft Office applications.
• Regular travel between sites required; ability to adapt to multiple GMP environments.

Responsibilities

• Provide validation support across multiple sites based on business priorities.
• Assist in equipment qualification (IQ/OQ/PQ), cleaning validation, process validation, and CSV.
• Execute and author validation protocols and reports.
• Support aseptic manufacturing and inspection/packaging validation activities.
• Issue validation data, protocols, reports, and technical memos.
• Support site change management programs and maintain validated states.
• Assist with Validation Master Plans and Continuous Process Verification activities.
• Review vendor turnover packages and User Requirement Specifications.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level