What are the responsibilities and job description for the Commissioning Lead Engineer position at United Pharma?
Position Overview
We are seeking an experienced C&Q Documentation Lead to support large-scale pharmaceutical manufacturing projects. This role will be responsible for leading the development, authoring, and management of commissioning and qualification documentation in a GMP-regulated environment.
Key Responsibilities
- Lead the development and authoring of C&Q documentation including protocols, reports, and supporting documents
- Independently create documentation from concept through final approval
- Author and manage change controls (CLIAs) aligned with regulatory and site requirements
- Collaborate with cross-functional teams to ensure timely and compliant project execution
- Engage with external vendors to resolve documentation and scope-related issues
- Support large capital (CapEx) projects and manage multiple priorities effectively
Required Qualifications
- Strong experience in C&Q documentation development (end-to-end)
- Hands-on experience with change controls (CLIAs) and URS documentation
- Proven experience in GMP / pharmaceutical manufacturing environments
- Experience working on large-scale capital projects (CapEx)
- Excellent communication, coordination, and stakeholder management skills
- Ability to work independently and manage multiple deliverables