Validation Engineer II

Company : Katalyst Healthcares & Life Sciences

Job Description:

A great opportunity for a Validation Engineer II to support QC laboratory equipment qualification activities within a world-class biopharmaceutical environment. This role ensures full compliance with cGMP, corporate quality standards, and regulatory expectations, all while contributing directly to patient safety and operational excellence.

Responsibilities:

• Perform equipment qualification per EQ policies and procedures.
• Partner with QC lab staff to define qualification requirements.
• Author, review & execute qualification protocols.
• Coordinate with vendors and cross-functional support teams.
• Identify quality, compliance, and operational gaps.
• Review/sign-controlled documentation per Genentech guidelines.
• Support QC operations with additional assignments.

Requirements:

• BS/BA in a relevant scientific discipline (preferred).
• Pharma or biopharma experience required.
• Knowledge of cGMP regulations.
• 2+ years in validation or equipment qualification (preferred).
• Ability to manage schedules, shifting priorities, and deadlines.
• Strong verbal & written communication.
• Ability to influence and build relationships.
• Strategic and execution-focused mindset.
• High accountability and ownership of deliverables.

Environment:

• Standard office/lab setting with required safety protocols.

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