Senior Compliance Engineer, Process Engineering
Core
Design, qualify, and validate process equipment and systems for aseptic pharmaceutical manufacturing environments, ensuring GMP compliance and supporting production operations.
Role type
Senior IC process engineering and compliance specialist
Builds
Aseptic fill-finish pilot plant operations and compliant manufacturing processes
Domain
Pharmaceutical manufacturing / Process Engineering
Required skills
GMP compliance, aseptic fill-finish operations, process equipment design, validation planning, root cause analysis, change control management, technical reporting, HVAC system knowledge, regulatory requirements translation
Preferred skills
Sterile manufacturing experience, project planning, budgeting, cross-functional collaboration, new technology implementation
Technologies
SAP Product Lifecycle Management, computerized systems
Responsibilities
Provide technical support for process equipment and production operations; lead troubleshooting and corrective actions for non-conformances; manage technical changes through change control; oversee technical work order systems; deliver training to operators; support evaluation and implementation of new technology platforms; collaborate on cross-functional engineering projects; plan and coordinate validation and scale-up activities; evaluate analytical results to maintain batch quality; propose and implement technology improvements.
Seniority
Senior, hands-on IC