i-Pharm GxP · 9 hours ago
CQV Engineer
Indiana, United States
Contract
Onsite
Mid, Senior Level
3+ years expi-Pharm GxP is seeking a CQV Engineer to support site-wide pre-implementation change control activities within a regulated GMP manufacturing environment. The role focuses on ensuring change controls are effectively progressed, documented, and closed in alignment with site procedures and quality expectations.
Management Consulting
Hiring Manager
Sam Walker
Responsibilities
Support the initiation, coordination, and closure of site change controls within the pre-implementation phase
Track change control status, milestones, and deliverables to ensure timely progression and closure
Assist with reporting, metrics, and dashboards related to change control performance and compliance
Coordinate with cross-functional stakeholders (Engineering, Quality, Validation, Manufacturing) to resolve gaps or delays
Ensure documentation is complete, accurate, and compliant with site quality systems
Support continuous improvement efforts related to change control processes and workflows
Qualification
Required
Typically 3–5+ years of experience in change control, quality systems, or GMP-regulated manufacturing environments
Strong understanding of pre-implementation change control within pharma, biotech, or life sciences
Experience working on-site in fast-paced manufacturing or capital project settings
Strong organizational, documentation, and stakeholder coordination skills
Company
i-Pharm GxP
Consulting Services to scope, staff, manage and deliver GxP solutions across North America, Europe and the Asia-Pacific.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase