Validation Engineer - Critical Utilities

Mykelly; Redwood City (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Mykelly in Redwood City, CA seeks a hands-on Validation Engineer for critical utilities at a pharma manufacturing site. This on-site contract role focuses on validation, qualification, and project management of purified water and nitrogen systems.

You will troubleshoot PW system, standardize maintenance, coordinate qualification activities, and work with vendors and technicians to bring systems online.

Qualifications

• Experience leading validation/qualification projects for critical utilities.
• Hands-on troubleshooting of PW and nitrogen systems.
• Ability to work onsite with technicians and vendors.
• Pharma/regulated environment experience preferred.

Responsibilities

• Troubleshoot PW system heater and lead replacement with vendor.
• Standardize vent filter installation and retrain technicians.
• Procure PW spool piece and test system automation for single-tank operation.
• Replace filter integrity tester and support requirements through qualification.
• Support nitrogen generator feasibility study with engineering firm.
• Coordinate project execution and qualification activities for critical utilities.

Skills

Project management

Validation/Qualification

Purified water systems

Nitrogen systems

On-site collaboration

Job description

Validation Engineer – Critical Utilities

Location: Redwood City, CA | Onsite Duration:Contract, 6+ months

Help improve and modernize critical utility systems at a pharmaceutical manufacturing site. We’re seeking a hands-on Validation Engineer with project management, validation, and qualification experience—especially with purified water and nitrogen systems.

What you’ll work on

• Troubleshoot the purified water (PW) system heater and develop a replacement solution with a vendor; the existing system is obsolete.
• Standardize vent filter installation, retrain technicians, and shorten the preventive maintenance interval.
• Procure a PW spool piece and test the system automation to operate one tank at a time.
• Replace the filter integrity tester, supporting the work from user requirements and design specifications through commissioning and qualification.
• Support a nitrogen generator feasibility study with an engineering firm.
• Coordinate project execution and qualification activities for critical utilities.

What you’ll bring

• Experience managing projects and executing validation or qualification for critical utilities.
• Specific experience with purified water and nitrogen systems.
• Ability to work onsite and collaborate with technicians, vendors, and engineering partners.