Associate. Specialist, Engineering
Core
Provide hands-on technical support for packaging and medical device assembly lines, troubleshooting equipment, managing change controls, and supporting new product transfers and equipment qualification.
Role type
Associate Specialist, Technical Operations Engineer (Manufacturing)
Builds
Packaging and medical device assembly lines at the Wilson site
Domain
Medical Device Manufacturing / Pharmaceutical Packaging
Deliverable
physical/clinical work
Required skills
Mechanical aptitude, Equipment troubleshooting, Change control management, Root cause analysis, Process monitoring, Documentation preparation, Project administration, Equipment qualification support
Preferred skills
GMP manufacturing experience, Medical Device/Combination Products experience, Lean Six Sigma tools, Vendor management
Technologies
None explicitly listed beyond general equipment types
Responsibilities
Troubleshoot packaging and device assembly equipment problems; Author quality incidents and support root cause analysis; Assist with design and qualification of new packaging components; Support scale-up and technology transfer for new products; Prepare and implement process change controls; Analyze equipment performance data and track issues; Organize technical documentation for regulatory audits; Manage project administration tasks like purchase orders and invoices.