CQV Validation Engineer (Parallel Manufacturing Enablement Project)

About the Project

Our client is launching a major Parallel Manufacturing Enablement Project within a regulated biotechnology manufacturing environment. The strategic goal of this initiative is to enable simultaneous manufacturing operations by eliminating shared-equipment dependencies and ensuring full segregation between production lines.

This project focuses on the qualification and integration support for new manufacturing equipment designed to replicate existing approved production assets. Key equipment scope includes single-use mixing systems, cell collection and hold tanks, and centrifuge systems with associated controls.

About the Role

As a Senior C&Q Validations Engineer, you will lead and support Commissioning, Qualification, and Validation (CQV) activities essential to bringing new manufacturing equipment into existing production workflows. You will be the technical anchor for the validation lifecycle, ensuring the seamless procurement, installation, qualification, and integration of assets while maintaining strict alignment with site procedures and inspection readiness expectations.

In this 100% onsite role based on the east side of Puerto Rico, you will operate within a fast-paced, regulated pharmaceutical environment. Your day-to-day involves coordinating cross-functional teams, managing complex validation projects, and resolving technical challenges that impact project execution. You will serve as a bridge between engineering, quality, manufacturing, and vendors, ensuring that all activities support compliant manufacturing operations and audit readiness.

Hiring Process

Candidates meeting the specified education and experience requirements will be reviewed for their expertise in CQV lifecycle management, regulatory compliance, and cGMP manufacturing systems. The selection process focuses on identifying individuals with proven leadership capabilities in validation engineering and strong technical writing skills.

Equal Opportunity

We are an equal opportunity employer committed to building a diverse and inclusive workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.