Engineer Senior

Engineer Senior Top 3 Must Have Skill Sets

• GMP & Packaging Equipment Expertise
  • Strong hands‑on experience in GMP‑regulated environments
  • Direct experience with packaging / device assembly equipment (automated or semi‑automated)
  • Involvement in commissioning, qualification, and validation (CQV)
• Technical Writing & Document Management Systems
  • Proven ability to author and manage GMP documents (protocols, reports, validation docs)
  • Experience with document management systems (preferably KNEAT or Veeva)
  • Ownership of deviations, CAPAs, and change controls
• Process Development & Continuous Improvement
  • Ability to analyze and optimize manufacturing processes
  • Experience driving efficiency, throughput, and performance improvements
  • Strong technical leadership in process/equipment optimization
  • Strong project management and team player skillset. Ability to work within different cross‑functional groups and coordinate projects.
• Nice to have:
  • Kneat/Veeva and former experience managing projects

• Weak or No GMP Experience
• Lack of Hands‑On Equipment Experience
• Poor Technical Writing / Documentation Skills
• No Process Improvement Mindset
• Limited Ownership or Leadership
• Weak Communication & Cross‑Functional Skills
• Inflexibility with Schedule or On‑Site Work

The Senior Process Development Engineer – Packaging Equipment supports commercial GMP Final Drug Product (FDP) operations in New Albany, Ohio. This is a technical leadership role requiring application of advanced engineering principles in equipment, devices, process optimization, and manufacturing support. The position requires on‑site support and ability to work a flexible schedule based on operation demands and both on‑site work and ~10% travel.

• Equipment & Manufacturing Support:
  • Provide on‑site support for GMP packaging and device assembly operations
  • Troubleshoot equipment issues and improve reliability/performance
  • Support automated and semi‑automated assembly lines
  • Monitor and trend equipment performance metrics
• Process Improvement & Optimization:
  • Identify and implement process improvements to increase throughput and efficiency
  • Analyze manufacturing data to drive continuous improvement initiatives
  • Optimize packaging line capacity and performance
• Documentation & Quality Systems:
  • Write, review, and manage GMP documents (protocols, reports, procedures)
  • Own and manage deviations, CAPAs, and change controls
  • Maintain and update the site master validation plan
  • Use systems like KNEAT or Veeva for document control
• Validation & Technical Projects (CQV):
  • Lead or support commissioning, qualification, and validation (CQV) activities
  • Support tech transfer of products into the Ohio site
  • Ensure equipment and processes meet regulatory and quality requirements
• Cross‑Functional
  
  Collaboration:
  
  
  • Work with manufacturing, quality, engineering, and external vendors
  • Coordinate with commercial and clinical teams
  • Communicate progress on technical milestones and projects
• Project & Vendor Management:
  • Support equipment‑related projects and timelines
  • Interface with equipment suppliers/vendors for troubleshooting and improvements
  • Contribute to standardization efforts across sites
• Flexible Operations Support
  • Work swing shifts (day/night/weekend as needed)
  • Provide support based on production demands
  • Occasional travel (~10%)
• Project Management
  • Support technical transfer of product portfolio into the Ohio site.
  • Drive continuous improvement in device assembly and packaging line capacity/performance.
  • Communicate across the network to deliver technical milestones.
• Technical Leadership
  • Act as site expert in automated/semi‑automated device assembly.
  • Lead commissioning, qualification, and validation (CQV) of GMP equipment.
  • Own and maintain the site master validation plan.
• Operational Excellence
  • Analyze, design, and implement manufacturing/business process improvements.
  • Drive productivity, throughput, and efficiency gains.
• Quality and Document Management Systems
  • Able to author and manage various documents/protocols/reports
  • Deviation/CAPA/EV Owner
  • Change Control Owner
• Relationships
  • Build networks with commercial and clinical operations.
  • Provide support for equipment standardization, troubleshooting, and performance trending

• Basic…