Biotech and Pharmaceutical, Change Control, Change Management, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Documentation, GMP (Good Manufacturing Practices), HVAC, Housekeeping/Cleaning, Manufacturing, Requirements Validation/Verification, Root Cause Analysis, System Validation, Systems Analysis, Systems Reliability, Team Player, Technical Support, Time Management, Writing Skills
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
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Stark Pharma Solutions Inc