Senior Process Engineer – Automated Visual Inspection

Civica

Petersburg (VA)

On-site

USD 90,000 - 120,000

Full time

13 days ago

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Job summary

Civica in Petersburg, Virginia, is seeking a Process Engineer II focused on automated visual inspection for vials, cartridges, and syringes. You will coordinate vendor activities from design through qualification and provide front-line manufacturing support.

The role requires 6+ years in process engineering, 3+ years with vision systems, and a BS in Engineering or Science. You will lead cross-functional teams, apply DMAIC/FMEA, and drive CI/ TPM to ensure compliant, scalable manufacturing.

Qualifications

  • 6+ years of Process Engineering experience.
  • 3 years of automated vision system experience.
  • Bachelor's degree in Engineering or Science.
  • Ability to manage teams to execute activities on the manufacturing floor.
  • Data-driven root cause analysis and prioritization of CI initiatives (Six Sigma, 5-why, fishbone).
  • Ability to adapt to changing priorities as project demands change.
  • Ability to explain complex technical issues to external customers/agencies.
  • Strong planning and organizational skills with excellent communication.
  • Project management experience.
  • Ability to work with outside suppliers.
  • Knowledge of Lean/Six Sigma methodologies.
  • Strong problem-solving skills with a hands-on mechanical aptitude.
  • Familiarity with engineering and architectural/construction drawings.
  • Willingness to own new technical challenges.
  • Passion for Civica's mission to provide affordable quality medicines.

Responsibilities

  • Coordinate equipment vendors through design, fabrication, installation, and qualification.
  • Support Commissioning & Qualification activities (FAT, SAT, IQ, OQ, PQ).
  • Draft engineering trials, DOEs, and cGMP documentation for production operations.
  • Draft risk assessments and specs for defect kits used in equipment qualification.
  • Coordinate technical deliverables across functions to support processes and launches.
  • Lead cross-functional teams to troubleshoot, drive CI/TPM, and resolve issues.
  • Manage changes per site change control procedures.
  • Participate in regulatory inspections (FDA, DEA audits).
  • Improve equipment reliability through CI and TPM for ramp-up production.
  • Prepare and update Preventative Maintenance tasks for production equipment.
  • Lead investigations related to equipment.

Skills

Process engineering
Automated vision systems
DMAIC
FMEA
Six Sigma
Project management
Lean methodologies
Root cause analysis
Vendor coordination
Cross-functional leadership
Communication skills
External customer communication

Education

Bachelor's degree in Engineering or Science

Tools

FAT
SAT
IQ/OQ/PQ
cGMP documentation

Job description

Civica in Petersburg, Virginia, is seeking a Process Engineer II focused on automated visual inspection for vials, cartridges, and syringes. You will coordinate vendor activities from design through qualification and provide front-line manufacturing support.

The role requires 6+ years in process engineering, 3+ years with vision systems, and a BS in Engineering or Science. You will lead cross-functional teams, apply DMAIC/FMEA, and drive CI/ TPM to ensure compliant, scalable manufacturing.

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