Senior GMP Utilities & HVAC Engineer – Sterile Injectables

BioSpace; Petersburg (VA); On-site; USD 120,000 - 180,000; Full time

Job summary

Civica is seeking a Principal Engineer: Utilities & HVAC for our new manufacturing site in Petersburg, VA. You will be the site SME for GMP HVAC and critical utility systems, ensuring compliant, safe, and reliable operation.

You will lead reliability initiatives, oversee design, qualification, and start-up activities, and mentor operations staff while driving continuous improvement and capital projects. Bachelor’s degree in engineering with 6+ years GMP utilities experience; prior start-up

Qualifications

• Bachelor’s degree in engineering or relevant sciences and 6+ years of experience with GMP Utilities.
• 5 years’ experience with sterile injectables, combo-devices, or biologics.
• Start-up experience preferred.

Responsibilities

• SME with deep technical expertise in GMP HVAC, GMP Utilities and related systems.
• Ensure processes align with regulatory Industry and Civica Standards.
• Lead or participate in design, verification and qualification activities (IV/OV/PQ).
• Develop URs, Specifications, test cases to demonstrate proper installation and launch of systems.
• Monitor KPI's for utility systems and ensure compliant operation.
• Provide technical assistance to maintenance and operations personnel.

Skills

GMP HVAC

Utilities management

Process control

IV/OV/PQ testing

CAPA systems

Education

Bachelor's degree in engineering

Tools

DMS

CAPA systems

Job description

Civica is seeking a Principal Engineer: Utilities & HVAC for our new manufacturing site in Petersburg, VA. You will be the site SME for GMP HVAC and critical utility systems, ensuring compliant, safe, and reliable operation.

You will lead reliability initiatives, oversee design, qualification, and start-up activities, and mentor operations staff while driving continuous improvement and capital projects. Bachelor’s degree in engineering with 6+ years GMP utilities experience; prior start-up