Job Title: Utilities Engineer

Location: Concord, NC (Onsite)

Duration: 12-Month Contract

Start Date: ASAP

Job Summary

We are seeking a Utilities Engineer with strong pharmaceutical industry experience to support utilities systems compliance, deviation investigations, and change control activities within a GMP-regulated manufacturing environment. This role will focus on maintaining operational reliability and ensuring compliant execution of quality systems activities related to clean utilities, dirty utilities, and HVAC systems.

The ideal candidate will have hands-on experience managing deviations, change controls, and regulated utility systems while collaborating cross-functionally with Engineering, Operations, and Quality teams.

Key Responsibilities

Lead and support deviation investigations related to site utility systems
Author, manage, and track change controls within Veeva Vault
Ensure timely completion and compliance of quality records, investigations, and supporting documentation
Collaborate with Engineering, Operations, and Quality teams to resolve technical and compliance-related issues
Perform root cause analysis and support implementation of CAPA actions
Evaluate system changes and assess impact on validated utilities systems
Provide technical support for utility system performance, reliability, and compliance initiatives
Support continuous improvement projects related to utilities operations and GMP compliance

Required Qualifications

Experience supporting utilities systems in pharmaceutical or GMP-regulated environments
Hands-on experience with deviation investigations and change control management
Strong knowledge of Veeva Vault and quality documentation systems
Understanding of GMP compliance and validated systems requirements
Strong troubleshooting, analytical, and documentation skills
Excellent communication and cross-functional collaboration abilities

Stark Pharma

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