Validation Engineer II

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

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.

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.

Qualifications

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.
SITE

California residents should review our Notice for California Employees and Applicants before applying.

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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