CAI

Process Engineer

CAI

full-time

Posted on:

Location Type: Office

Location: Providence • Rhode Island • 🇺🇸 United States

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Salary

💰 $36 - $50 per hour

Job Level

Mid-LevelSenior

About the role

  • Design, operate, install, troubleshoot, commission, and qualify cGMP manufacturing process activities within isolators or biosafety cabinets
  • Support sterile operations including vial, prefilled syringe, and cartridge filling lines
  • Contribute to pilot and commercial scale bioreactors, centrifugation, chromatography skids, ultrafiltration/diafiltration, depth filtration, and lyophilization/freeze drying processes
  • Work with automated visual inspection systems, automated formulation systems, autoclaves, and CIP/SIP systems
  • Assist in developing validation/verification master plans, commissioning plans, and qualification protocols
  • Perform formal risk assessments (e.g., FMEA) and identify critical attributes and process parameters
  • Develop and maintain project plans, schedules, and issue tracking for client projects
  • Ensure compliance with regulatory requirements, industry standards, and company quality expectations

Requirements

  • BS or MS in a relevant engineering or science field, or equivalent experience
  • Three (3) or more years of experience in aseptic process engineering or validation in biotech or pharmaceutical industries
  • Excellent oral and written communication skills in English
  • Team-oriented, customer-service focused, and able to collaborate effectively with cross-functional teams
  • Ability to travel domestically and internationally as required
  • Ability to work (paid) overtime as needed
  • Eligible to work in the U.S. without sponsorship now or in the future
  • Experience with commissioning and qualification projects in regulated industries (preferred)
  • Background in developing user requirements, risk assessments, and traceability matrices (preferred)
  • Proficiency in project management including planning, estimating, scheduling, and issue resolution (preferred)
  • Familiarity with regulatory and industry standards for aseptic processes and validation (preferred)
Benefits
  • Comprehensive Health Insurance coverage
  • 24 days of Paid Time Off
  • ESOP/401K - 15% Company Contribution (US Only)
  • Company paid Life Insurance
  • Company paid Long Term Disability
  • Retirement contribution
  • Generous PTO
  • Professional education support
  • Competitive compensation

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
cGMP manufacturingaseptic process engineeringvalidationcommissioningrisk assessmentsproject managementbioreactorschromatographylyophilizationdepth filtration
Soft skills
communication skillsteam-orientedcustomer-service focusedcollaborationissue resolution