Senior Engineer
$85,000–$100,000 year
On-site · Illinois, United States or New Albany, Ohio, United States
Job Summary
Lead and manage multiple GMP validation and qualification projects for equipment, utilities, facilities, systems, and processes in a life sciences manufacturing environment. Develop specifications and supporting documentation (URS, RA, FS); oversee commissioning and qualification activities; design, execute, and review complex validation/qualification studies; manage multiple concurrent initiatives; facilitate cross-functional team meetings; contribute to capital forecasting and resource planning; provide technical oversight of analytical instrumentation and environmental monitoring tools; collaborate with experts to troubleshoot issues and implement compliant solutions; act as technical authority for process and equipment optimizations; lead deviation investigations, CAPA implementation, and SOP revisions to ensure regulatory compliance; leverage digital tools (QMS, eDMS, MS Office) to streamline documentation and reporting; mentor junior team members and support broader site initiatives.
Required Qualifications
- Minimum Bachelors’ degree in Engineering, Science, or related field
- 5+ years’ experience in GMP manufacturing environment
- Expertise in cleaning validation, qualification of aseptic filling or formulation equipment/processes
- Experience with temperature validation equipment
- Strong writing, communication, and interpersonal skills
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